Food and Drug Administration (FDA) News 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.Traces of bird flu found in pasteurized milk, FDA says, with virus traveling from birds, to cattle, to humans, and chickens
The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows. The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to…#fda #avian #leeannjaykus (Source: Reuters: Health)
Source: Reuters: Health - April 24, 2024 Category: Consumer Health News Source Type: news
FDA Urges Public to Use Heimlich Not'Anti-Choking' Devices to Save Lives
TUESDAY, April 23, 2024 -- The U.S. Food and Drug Administration is advising people to use the Heimlich maneuver to aid a choking victim and not rely on over-the-counter anti-choking devices. " The safety and effectiveness of over-the-counter... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 23, 2024 Category: Pharmaceuticals Source Type: news
FDA Roundup: April 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma
On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutati (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Column: FDA shoots itself in the foot by settling a groundless lawsuit over its ivermectin warnings
“You are not a horse”: The FDA’s 2021 consumer warning about not treating COVID with ivermectin, best known as a horse dewormer, was the most successful social media post in its history. “You are not a horse,” read a tweet posted by the Food and Drug Administration on Aug. 21, 2021. A fairly…#fda #linkedin #5thcircuits #donaldtrump #georgewbush #doritrubinsteinreiss #uccollegeoflaw #supremecourt #aduhelm #biogen (Source: Reuters: Health)
Source: Reuters: Health - April 23, 2024 Category: Consumer Health News Source Type: news
FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS
On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NE (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Exo launches cardiac, lung AI apps for Exo Iris
Exo’s cardiac and lung AI applications are now available on Exo Iris, its handheld ultrasound device.
The company released Exo Iris last year. The point-of-care-ultrasound (POCUS) device now features pulsed-wave Doppler capabilities to offer physicians more opportunities to assess blood velocity and thus support diagnosis and deeper findings in cardiac, abdominal, and vascular applications, according to the firm.
Exo has U.S. Food and Drug Administration (FDA) 510k clearances for cardiac, lung, bladder, hip, and thyroid applications, and plans to double the number of clearances by 2025, it said. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 23, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news
Stick to Heimlich Maneuver Not'Anti-Choking' Devices, FDA Says
TUESDAY, April 23, 2024 -- People should rely on the well-established Heimlich maneuver to save a choking victim, rather than newfangled “anti-choking” devices, the U.S. Food and Drug Administration says.“The safety and effectiveness of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 23, 2024 Category: General Medicine Source Type: news
FDA: Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
Notice from the Food and Drug Administration (FDA) seeking comments on a proposed generic information collection to support social and behavioral research used by FDA about drug products. Comments are due by June 24, 2024. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - April 23, 2024 Category: Rural Health Source Type: news
FDA approves bladder cancer treatment by Culver City company
The Food and Drug Administration on Monday approved Culver City-based ImmunityBio's treatment for a type of bladder cancer. (Source: Los Angeles Times - Science)
Source: Los Angeles Times - Science - April 23, 2024 Category: Science Authors: Times staff Source Type: news
Alecensa Approved as First and Only ALK Inhibitor for Non-Small Cell Lung Cancer
MONDAY, April 22, 2024 -- The U.S. Food and Drug Administration has approved Alecensa (alectinib) as adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).The... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 22, 2024 Category: Pharmaceuticals Source Type: news
FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Gu érin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papilla (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
U.S. government in hot seat for response to growing cow flu outbreak
In early March, veterinarian Barb Peterson noticed the dairy cows she cared for on a Texas farm looked sick and produced less milk, and that it was off-color and thick. Birds and cats on the farm were dying, too. Peterson contacted Kay Russo at Novonesis, a company that helps farms keep their animals healthy and productive. “I said, you know, I may sound like a crazy, tinfoil hat–wearing person,” Russo, also a veterinarian, recalled at a 5 April public talk sponsored by her company. “But this sounds a bit like influenza to me.”
She was right, as Peterson and Russo soon learned. On 19 March, birds on the Tex...
Source: ScienceNOW - April 22, 2024 Category: Science Source Type: news
FDA clears Philips Zenition 30 mobile C-arm
Philips parent Royal Philips has secured clearance from the U.S. Food and Drug Administration (FDA) for its Zenition 30 mobile C-arm.
Zenition 30 offers greater control over C-arm positioning during surgical procedures, with pushbuttons on the flat detector that allow clinicians to unlock and adjust the arm’s horizontal, orbital, and rotational positioning, the company said. It also features Philips’ MetalSmart software, which automatically adjusts image contrast and brightness to improve image quality and eliminate blooming while maintaining a low radiation dose, according to the firm.
Philips first introduced the...
Source: AuntMinnie.com Headlines - April 22, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news
Abeona Therapeutics Provides Regulatory Update on Pz-cel
CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 22, 2024 Category: Drugs & Pharmacology Source Type: news
