MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'fda approvals'. Sat, 03 Sep 2011 02:50:10 +0100 http://www.medworm.com/index.php?rid=4399663&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F38647165%2Fwill_the_ab_sonic_help_you_improve_your_level_of_fitness.php © theflexbelt.comThere are many ailments that can be improved by doing some exercise. High blood pressure, for example, can be relieved if the cause is excess weight. In general, keeping fit helps maintain a healthy body. There are lots of products advertised to help with toning muscles and strengthening the core of the body, and as a result help with weight loss. One of these is the ab sonic. But does it work? If you are serious about getting healthy, then you need to ... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=4399663 Fri, 26 Nov 2010 21:57:32 +0100 4399663 http://www.medworm.com/index.php?rid=3865341&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fellaa_got_approved_by_the_us_fda.php EllaOneMove Over morning-after pill! Ella™ just got approval from the US FDA for emergency contraception. Ella™ (ulipristal acetate) has been available in Europe for a year before it got to the US market. Ella™ works by inhibiting or delaying ovulation by interfering with the effects of the female hormone progesterone -- which stimulates ovulation. According to the US FDA: "Ella™ successfully prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended ... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=3865341 Sat, 14 Aug 2010 00:40:19 +0100 3865341 http://www.medworm.com/index.php?rid=2662548&cid=t_140074_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2F0APSdfQFcBQ%2F The FDA in the United States has approved a new medication for the management of type 2 diabetes. Onglyza (saxagliptin) is taken once a day to help normalize blood sugar levels. Currently, management of type 2 diabetes includes a lifestyle component (healthy diet and exercise) as the first part. If lifestyle changes don’t help regulate blood sugar issues or the diabetes is too severe, doctors have a few options for medications. Usually, type 2 diabetes is managed first with oral antihyperglycemics, pills that help the pancreas and insulin work more effectively. The main difference between type 1 diabetes and type 2 diabetes is that with type 1, the pancreas doesn’t produce any insulin. To manage this, people with type 1 diabetes must inject themselves with insulin at least once... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2662548 Sun, 02 Aug 2009 11:02:58 +0100 2662548 http://www.medworm.com/index.php?rid=2415517&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fotc_prevacida_heartburn_medicine_now_fdaapproved.php More than 50 million Americans suffer from frequent heartburn, and nearly half-more than 21 million patients-utilize prescription-only Prevacid® to treat acid-related disorders. The US FDA recently ... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=2415517 Fri, 15 May 2009 22:09:53 +0100 2415517 http://www.medworm.com/index.php?rid=2200477&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fbrain_device_for_severe_ocd_approved_by_the_fda.php Photo courtesy of iStockphoto, Image# 3648499 The US FDA has approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=2200477 Fri, 20 Feb 2009 02:39:09 +0100 2200477 http://www.medworm.com/index.php?rid=2067382&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fvasovist_first_imaging_agent_to_enhance_scans_of_blood_flow_fdaapproved.php Photo courtesy of iStockphoto, Image# 6980088 Vasovist Injection (gadofosveset trisodium) - the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA - has... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=2067382 Sun, 28 Dec 2008 02:42:51 +0100 2067382 http://www.medworm.com/index.php?rid=1870647&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.creative-weblogging%2Faudio%2F%2Fhttp%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Flev_pharmas_cinryzea_got_fda_marketing_approval_for_hae.php A rare genetic and life threatening disease, hereditary angioedema (HAE) is an autosomal dominant disorder of C1 inhibitor (C1-INH) deficiency manifested by painless, nonpruritic, nonpitting swelling of the skin. Now, LEV Pharma's Cinryze™ has been given marketing approval for the protection of people with HAE. The product, called Cinryze, is licensed for the prevention of HAE attacks, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease. Attacks can produce rapid swelling of the hands, feet, limbs, face, intestinal tract or airway. Swelling of the larynx can lead to asphyxiation. Cinryze is a C1-esterase inhibitor product derived from human plasma. This plasma protein regulates clotting and inflammatory reactions that, when... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1870647 Mon, 13 Oct 2008 08:00:00 +0100 1870647 http://www.medworm.com/index.php?rid=1794370&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fmercks_gardasil_approved_for_new_uses.php 5255912 Photo courtesy of iStockphoto, Image# 5255912 The US FDA has recently approved additional uses for Merck's controversial HPV vaccine Gardasil: prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. "There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. "While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV." The FDA originally approved Gardasil in 2006 for girls and women ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1794370 Tue, 16 Sep 2008 09:44:43 +0100 1794370 http://www.medworm.com/index.php?rid=1696128&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2F20082009_flu_vaccines_approved_by_the_fda.php Photo courtesy of iStockphoto, shannon drawe Earlier this week, the FDA has announced its approved flu vaccines for the 2008-2009 flu season in the United States. Six vaccines approved and their manufacturers are: Afluria by CSL Limited Fluarix by GlaxoSmithKline Biologicals FluLaval by ID Biomedical Corporation of Quebec FluMist by MedImmune Vaccines Inc. Fluvirin by Novartis Vaccines and Diagnostics Limited Fluzone by Sanofi Pasteur Inc. This season's vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the United States. Each season's vaccines are modified to reflect the virus strains most likely to be circulating. The closer the match between the circulating strains and the strains in the vaccines, the ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1696128 Mon, 11 Aug 2008 05:43:01 +0100 1696128 http://www.medworm.com/index.php?rid=1581894&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ffirst_generic_risperdal_risperidone_fdaapproved.php The first generic versions of Risperdal (risperidone) tablets has recently been approved by the FDA. A product of Janssen - Risperdal - is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. "This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research. Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Read more from FDA News. [Photo Credit] See full article. Related Entries: Generic Allegra from Mylan Laboratories - 13 April 2006 Bipolar Disorder - 10 M... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1581894 Sun, 06 Jul 2008 03:48:00 +0100 1581894 http://www.medworm.com/index.php?rid=1531167&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fneurx_dps_ra4_respiratory_stimulation_system_fdaapproved.php An implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator - NeuRx DPS RA/4 Respiratory Stimulation System - has been approved by the US FDA. Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine. The NeuRx DPS RA/4 uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the patient to inhale. The FDA approved the distribution of this device under a Humanitarian Device Exemption, an approval process for devices intended to treat or diagnose condi... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1531167 Thu, 19 Jun 2008 12:28:27 +0100 1531167 http://www.medworm.com/index.php?rid=1463736&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fenterega_alvimopan_fdaapproved_for_postsurgery_bowel_function.php The FDA has recently approved Entereg® (Alvimopan) for help to restore bowel function after surgery. Entereg® (Alvimopan) is a first-in-class small molecule, peripherally-acting mu opioid receptor (PAM-OR) antagonist designed to block the adverse side effects of opioid analgesics on the GI tract without blocking their beneficial analgesic effects. Entereg® (Alvimopan) is a product of Adolor Corporation in collaboration with GlaxoSmithKline. Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-pr... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1463736 Fri, 23 May 2008 09:42:37 +0100 1463736 http://www.medworm.com/index.php?rid=1433728&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ffirst_generic_ropinirole_approved_by_the_fda.php Requip (ropinirole hydrochloride) tablets - product of GlaxoSmithKline (GSK) - are for the treatment of moderate to severe Restless Legs Syndrome (RLS). © Brymo From the NINDS-NIH: Restless legs syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and an uncontrollable urge to move when at rest in an effort to relieve these feelings. RLS sensations are often described by people as burning, creeping, tugging, or like insects crawling inside the legs. Often called paresthesias (abnormal sensations) or dysesthesias (unpleasant abnormal sensations), the sensations range in severity from uncomfortable to irritating to painful. Now the FDA has approved the generic versions of Requip - Ropinirole Hydrochloride. The said generics approved are from the ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1433728 Sat, 10 May 2008 06:12:29 +0100 1433728 http://www.medworm.com/index.php?rid=1396200&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fucbs_cimzia_fdaapproved_for_chrons_disease.php With no cure and still of unknown cause - Crohn's disease - is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. Chron's disease can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. Now, the US FDA has approved Cimzia (certolizumab pegol) for the treatment of adults with moderate to severe Crohn's disease who have not responded to conventional therapies. "Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research. "This drug works to reduce the signs and symptoms of Crohn&#3... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1396200 Thu, 24 Apr 2008 08:00:00 +0100 1396200 http://www.medworm.com/index.php?rid=1352015&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Frotaviruscaused_gastroenteritis_vaccine_rotarix_approved_by_us_fda.php Rotarix - the second oral U.S. licensed vaccine for the prevention of rotavirus (an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children) - has been approved by the US FDA. There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains. "This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions re... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1352015 Fri, 04 Apr 2008 15:15:12 +0100 1352015 http://www.medworm.com/index.php?rid=1315351&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ffibrin_sealant_artiss_fdaapproved_for_burn_patients.php A new medical adhesive - a fibrin sealant - called Artiss for use in attaching skin grafts onto burn patients, has just been approved by the US FDA. Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss (Fibrin Sealant, VH S/D 4) differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows surgeons more time to position skin grafts over burns before the graft begins to adhere to the skin. Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots. "The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," said Jesse L. Goodman M.D., M.P.H., director of FDA&... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1315351 Thu, 20 Mar 2008 02:47:44 +0100 1315351 http://www.medworm.com/index.php?rid=1279425&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnexium_fdaapproved_for_pediatric_gerd.php Last week, the FDA has approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age. "This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions." Nexium is part of a class of d... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1279425 Wed, 05 Mar 2008 05:03:33 +0100 1279425 http://www.medworm.com/index.php?rid=1265117&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Farcalyst_new_orphan_drug_fdaapproved_for_treatment_of_rare_inflammatory_syndromes.php The FDA has just approved a new orphan drug for the treatment of rare inflammatory syndromes. The said dug - Arcalyst - is the first treatment for an extremely rare condition known as Cryopyrin-Associated Periodic Syndrome or CAPS. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). Symptoms of both of these disorders include inflammation such as joint pain, rash or skin lesions, fever and chills, eye redness or pain, and fatigue in both children and adults; however MWS is associated with more severe inflammation and may include hearing loss or deafness. In addition, some MWS patients may also be af... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1265117 Thu, 28 Feb 2008 16:47:06 +0100 1265117 http://www.medworm.com/index.php?rid=1165301&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fabbotts_humirar_adalimumab_fdaapproved_for_moderate_to_severe_chronic_plaque_psoriasis.php The US FDA has recently approved the marketing of Abbott's HUMIRA(R) (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis. Plaque psoriasis is an autoimmune disease characterized by skin lesions that are sometimes painful and itchy. HUMIRA has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1165301 Mon, 21 Jan 2008 08:00:00 +0100 1165301 http://www.medworm.com/index.php?rid=1150649&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ftysabri_natalizumab_fdaapproved_for_moderatetosevere_crohns_disease.php (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1150649 Tue, 15 Jan 2008 09:01:06 +0100 1150649 http://www.medworm.com/index.php?rid=1132685&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fxtag_respiratory_viral_panel_fdacleared_for_marketing.php The FDA has recently cleared for marketing, the very first test that can simultaneously detect and identify 12 specific respiratory viruses in one sample. The said test, called the xTAG Respiratory Viral Panel (RVP) - (RVP) is a diagnostic test for the detection of multiple viral strains and subtypes designed to allow better decision-making in patient management and to limit the spread of infection. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001. The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, sp... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1132685 Mon, 07 Jan 2008 08:00:00 +0100 1132685 http://www.medworm.com/index.php?rid=1121700&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fvoluvena_approved_by_the_fda_for_treatment_of_serious_blood_volume_loss_postsurgery.php The FDA has recently approved Voluven® for the treatment of serious blood volume loss following surgery. Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues. Severe loss of blood volume can happen during or after surgery. In both cases, loss of blood volume is dangerous. Voluven® is an intravenous solution that prevents and treats a dangerous loss of blood volume. Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1121700 Sat, 29 Dec 2007 18:00:00 +0100 1121700 http://www.medworm.com/index.php?rid=1106972&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fkuvana_sapropterin_dihydrochloride_fdaapproved_for_phenylketonuria_pku.php Phenylketonuria (PKU) is a rare genetic disorder that causes mental retardation, smaller brain size, delayed speech and other neurological problems. If diabetes is characterized by the body not being able to metabolize sugar thereby resulting in high levels of glucose in the blood, PKU is characterized as the body not being able to metabolize phenylalanine (Phe), thereby resulting to high levels of Phe in the blood. PKU is a genetic disorder in which the enzyme phenylalanine hydroxylase (PAH), which helps our bodies break down phenylalanine (Phe), an amino acid found in foods, does not function properly. The result is high levels of phenylalanine in the blood. High levels of Phe are toxic to the brain and can lead to mental retardation, behavioral abnormalities, seizures, an inabilit... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1106972 Thu, 20 Dec 2007 03:53:22 +0100 1106972 http://www.medworm.com/index.php?rid=1037736&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnexavara_sorafenib_fdaapproved_for_inoperable_hepatocellular_carcinoma.php Originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma (a form of kidney cancer) - Nexavar® (sorafenib) has recently been approved by the FDA for use in patients with a form of liver cancer known as hepatocellular carcinoma -- when the cancer is inoperable. According to Robert Justice, M.D., director of FDA's division of drug oncology products: "In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug. This is an important new treatment option for patients who are fighting this very difficult form of cancer." Manufactured by Bayer HealthCare AG (Leverkusen, Germany) for Bayer Pharmaceuticals Corporation (West... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1037736 Tue, 20 Nov 2007 13:24:58 +0100 1037736 http://www.medworm.com/index.php?rid=993133&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ftasigna_nilotinib_fdaapproved_for_philadelphia_chromosome_positive_cml.php Novartis Pharma's Tasigna (nilotinib) has recently been approved by the US FDA for the treatment of Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients whose disease has progressed on or who cannot tolerate other therapies that included imatinib (Gleevec). FDA's approval of Tasigna includes a black box warning for possible life-threatening heart problems that may lead to an irregular heartbeat and possible sudden death. The effectiveness of Tasigna is based on response rates observed in an ongoing clinical trial. Responses are associated with normalization of blood counts and bone marrow examinations. Further follow-up of patients is needed to determine how long these responses will last. The abnormal chromosome called the Philadelphia chromosom... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=993133 Wed, 31 Oct 2007 06:41:34 +0100 993133 http://www.medworm.com/index.php?rid=974176&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnew_fdaapproved_label_of_ed_drugs_contains_risk_of_hearing_loss.php Revisions of the labeling of ED drugs (Cialis, Levitra and Viagra) that includes the potential risk of sudden hearing loss have already been approved by the FDA. The said approval will also apply for the drug Revatio (also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors) even though Revatio is used to treat pulmonary arterial hypertension (PAH) - a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle (often leading to right heart failure and death). Erectile dysfunction (ED) drugs will noe display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing. Patients taking Cialis, Levitra, or Viagra wh... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=974176 Wed, 24 Oct 2007 12:11:27 +0100 974176 http://www.medworm.com/index.php?rid=971389&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnew_bristolmeyers_squibbs_new_anticancer_treatment_ixempra_fdaapproved.php A new anti-cancer treatment distributed by Bristol-Meyers Squibb Company (Princeton, New Jersey) -Ixempra (ixabepilone) - has recently been approved by the US FDA for use use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs. The approval of Ixempra includes the following: for use in combination with another cancer drug (capecitabine) in patients who no longer benefit from two other chemotherapy treatments: including an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel)for use alone in patients who no longer benefit from an anthracycline, a taxane and capecitabine Administered by intravenous infusion, Ixempra has been shown to bind to cancer cell microtubules but with some sid... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=971389 Tue, 23 Oct 2007 07:29:53 +0100 971389 http://www.medworm.com/index.php?rid=915032&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Flamisil_fdaapproved_for_pediatric_treatment_of_scalp_ringworm.php We know Lamisil Tablets as a treatment for nail fungus infection (onychomycosis) whose generic versions have been approved by the FDA in July of this year. Now, the FDA has just approved Lamisil Oral Granules for the treatment of tinea... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=915032 Sun, 30 Sep 2007 11:19:44 +0100 915032 http://www.medworm.com/index.php?rid=886233&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnasal_influenza_vaccine_flumista_now_fdaapproved_for_children_ages_25.php Previously the nasal influenza vaccine Flumist® is limited to healthy children aged 5 and older and adults up to 49 years of age. Now, it has been recently approved by the US FDA to include children aged 2-5. According to... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=886233 Thu, 20 Sep 2007 12:00:00 +0100 886233 http://www.medworm.com/index.php?rid=874921&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fosteoporosis_drug_evista_fdaapproved_for_risk_reduction_of_invasive_breast_cancer.php A product of Eli Lilly - Evista (raloxifene hydrochloride) was previously indicated for the treatment of osteoporosis in postmenopausal women. Now, the FDA has recently approved the second indication of Evista: reducing the risk of invasive breast cancer in postmenopausal... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=874921 Sun, 16 Sep 2007 09:29:27 +0100 874921 http://www.medworm.com/index.php?rid=856748&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ffirst_generic_versions_of_corega_fdaapproved.php Coreg™ - a product of GlaxoSmithKline - is a widely used FDA-approved medication for the treatment of high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack. Now, the FDA has recently approved... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=856748 Mon, 10 Sep 2007 13:16:52 +0100 856748 http://www.medworm.com/index.php?rid=837433&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fsomatuline_depot_lanreotide_acetate_injection_fdaapproved_for_treatment_of_acromegaly.php [photo credit: faqs.org] Acromegaly is a a rare and potentially life threatening disease in adults caused by abnormal secretion of growth hormone (GH), commonly from a benign tumor located in the pituitary gland located in the brain. Just recently, the... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=837433 Mon, 03 Sep 2007 08:00:00 +0100 837433 http://www.medworm.com/index.php?rid=827983&cid=t_140074_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fevithrom_human_thrombin_fdaapproved_for_topical_use_in_surgery.php Evithrom (human thrombin) - manufactured by Omrix Biopharmaceuticals, Ltd. and will be distributed by Johnson & Johnson Wound Management (a division of Ethicon, Inc.) - is the first human thrombin approved since 1954 and the only product currently licensed. Evithrom... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=827983 Wed, 29 Aug 2007 08:00:00 +0100 827983 http://www.medworm.com/index.php?rid=800175&cid=t_140074_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F144376937%2F Blame it on Bush? There were just 38 NDA approvals through July, down 31 percent year-over-year from last year’s 55 and 16 percent below the 10-year average of 45, writes Jim Kumpel, a healthcare analyst at Friedman Billings Ramsey, in an investor note this morning. And the 7 new molecular entities approved through July is down 30 percent year-over-year, marking a 10-year low and 50 percent below July 2004. He points out that, during the first 79 months of the Bush administration, drug approvals have significantly lagged the averages logged under the Clinton administration. Under Bush, the FDA has averaged 80.8 NDA and 20.7 NME approvals per year, both down from the Clinton era’s average of 92.1 NDA and 32.4 NME approvals annually. It’s also true that, other than Mark McC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=800175 Wed, 15 Aug 2007 12:50:00 +0100 800175