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Management: Food and Drug Administration (FDA)
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Total 5166 results found since Jan 2013.
A Top New York Hospital, an Unapproved Treatment and an F.D.A. Warning
A product made from umbilical cord blood was used in spine surgeries at a Manhattan hospital. After a federal warning came an internal complaint: Patients should have been told.
Source: NYT Health - September 20, 2023 Category: Consumer Health News Authors: Ellen Gabler, Steve Eder and Allie Pitchon Tags: Hospitals Blood Biotechnology and Bioengineering Ethics and Official Misconduct New York-Presbyterian Hospital Food and Drug Administration Surgery and Surgeons Regulation and Deregulation of Industry Medicine and Health Research Burst Source Type: news
How Much Do Patients Need to Know About a Potentially Risky Treatment?
An unapproved product made from umbilical cord blood was used at a prominent New York hospital. After an F.D.A. warning came an internal complaint: Patients should have been told.
Source: NYT Health - September 20, 2023 Category: Consumer Health News Authors: Ellen Gabler, Steve Eder and Allie Pitchon Tags: Hospitals Blood Biotechnology and Bioengineering Ethics and Official Misconduct Burst Biologics New York-Presbyterian Hospital Food and Drug Administration Surgery and Surgeons Regulation and Deregulation of Industry Medicine and Health Source Type: news
Success of MDMA in PTSD Study Could Pave the Way for U.S. Approval of the Psychedelic
The psychedelic drug MDMA can reduce symptoms of post-traumatic stress disorder, researchers reported in a new study published Thursday.
The company sponsoring the research said it plans later this year to seek U.S. approval to market the drug, also known as ecstasy, as a PTSD treatment when combined with talk therapy.
“It’s the first innovation in PTSD treatment in more than two decades. And it’s significant because I think it will also open up other innovation,” said Amy Emerson, CEO of MAPS Public Benefit Corporation, the research sponsor.
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Source: TIME: Health - September 15, 2023 Category: Consumer Health News Authors: CARLA K. JOHNSON / AP Tags: Uncategorized wire Source Type: news
With the Decongestant SNAFU, the FDA Tries Something New
It’s easy to understand how a medicine like phenylephrine got onto pharmacy shelves in the first place. The common decongestant, used most often as an ingredient in multidrug cold medications like DayQuil and Sudafed PE, was initially designated as “safe and effective” by the Food and Drug Administration (FDA) in 1976, when the agency was newly—and less stringently than today—greenlighting drugs that had been on the market for years before the agency had established any efficacy standards. After a full review of 14 studies (12 unpublished and two published) from pharmaceutical companies—...
Source: TIME: Health - September 14, 2023 Category: Consumer Health News Authors: Haley Weiss Tags: Uncategorized healthscienceclimate Source Type: news
What to Know About the New COVID-19 Vaccine Booster
In a long-awaited update to the COVID-19 vaccine schedule, the U.S. Centers for Disease Control (CDC)’s vaccine committee recommended that everyone six months or older should get another booster shot.
In a long-awaited update to the COVID-19 vaccine schedule, the U.S. Centers for Disease Control (CDC) recommended on Sept. 12 that everyone six months or older should get another booster shot. CDC director Dr. Mandy Cohen endorsed the recommendation made by the agency’s committee of outside vaccine experts.
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That shot will be the newest vaccine greenlit by the Foo...
Source: TIME: Health - September 13, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news
FDA rules TODAY that ingredient in Benadryl and Sudafed from pharmacy shelves doesn't work
The Food and Drug Administration ruled that a common medicine for nasal stuffiness found in common decongestants is ineffective. It is metabolized in the gut and doesn't reach the nose.
Source: the Mail online | Health - September 12, 2023 Category: Consumer Health News Source Type: news
New COVID Vaccines Force Bivalents Out New COVID Vaccines Force Bivalents Out
Bivalent vaccines lost their authorization for use in the United States after a decision announced today by the Food and Drug Administration focuses new vaccine efforts on circulating variants.WebMD Health News
Source: Medscape Pulmonary Medicine Headlines - September 11, 2023 Category: Respiratory Medicine Tags: Infectious Diseases News Source Type: news
Should I get a COVID-19 booster?
On 12 September, a vaccine advisory group to the Centers for Disease Control and Prevention (CDC) once again will wrestle with the question of who in the United States should receive a booster shot to protect against COVID-19.
As several new variants and an uptick in COVID-19 hospitalization fuel concerns among some health officials and the public, three companies have made new COVID-19 vaccines that can be used as a booster (or as primary doses for the unvaccinated). The Food and Drug Administration (FDA) is expected to approve at least one of these latest iterations before Tuesday’s meeting of CDC’s Advisory Com...
Source: Science of Aging Knowledge Environment - September 8, 2023 Category: Geriatrics Source Type: research
Opioid and Benzodiazepine Co-Prescribing Trends from the Emergency Department from 2012-2019: A National Analysis
In 2016, the Food and Drug Administration (FDA) issued its strongest safety warning (Black Box) for concomitant use of prescription opioids and benzodiazepines due to overdose deaths.
Source: The Journal of Emergency Medicine - September 4, 2023 Category: Emergency Medicine Authors: Christine Ramdin, George Mina, Lewis Nelson, Maryann Mazer-Amirshahi Tags: Original Contributions Source Type: research
Using behavioral theory to understand partisan differences in COVID-19 vaccination and booster intentions
AbstractIn 2020, the Food and Drug Administration granted emergency use authorization for two COVID-19 vaccines. Two years later, the Centers for Disease Control and Prevention estimated that more than 250 million individuals had received at least one dose of the vaccine. Despite the large numbers of individuals vaccinated against COVID-19, partisan differences surrounding the COVID-19 vaccine emerged, creating a potential challenge for health communications aimed at increasing vaccine uptake. A better understanding of partisan differences in attitudes and intentions towards vaccination may help guide public health strateg...
Source: Journal of Behavioral Medicine - September 2, 2023 Category: Psychiatry Source Type: research
Roche ’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer
ALINA data demonstrateAlecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced settingAbout half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cureThese data will be submitted to health authorities globallyand presented at an upcoming medical meetingBasel, 01 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III ALINA study evaluating Alecens...
Source: Roche Media News - September 1, 2023 Category: Pharmaceuticals Source Type: news
Breast cancer immunotherapy: a comprehensive review
AbstractCancer remains a major health problem despite numerous new medical interventions that have been introduced in recent years. One of the major choices for cancer therapy is so-called adoptive cell therapy (ACT). ACT can be performed using both innate immune cells, including dendritic cells (DCs), natural killer (NK) cells, and γδ T cells and acquired immune T cells. It has become possible to utilize these cells in both their native and modified states in clinical studies. Because of considerable success in cancer treatment, ACT now plays a role in advanced therapy protocols. Genetic engineering of autologous and al...
Source: Clinical and Experimental Medicine - September 1, 2023 Category: Research Source Type: research
These Are the Shots You Should Get This Fall and Winter
It used to be relatively easy and straightforward to navigate the fall and winter respiratory disease season in the U.S.—get a flu shot. Then came COVID-19, and another vaccine was added to the mix.
Now, for the first time, there will be a third shot for some groups: a vaccine for respiratory syncytial virus (RSV), which causes respiratory disease that can be especially dangerous for infants and older people.
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Here’s what experts say about who should be receiving which shots, and when.
Flu (the easy one)
The advice here is straightforward and the same as ...
Source: TIME: Health - August 30, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news
