FDA grants orphan drug designation to potential treatment of STXBP1 developmental and epileptic encephalopathy
Research that was carried out by Baylor College of Medicine and Texas Children's Hospital doctors has led to the U.S. Food ...
FierceBiotech1d
FDA clears Omron blood pressure cuff with afib pulse wave detection
The FDA has granted a de novo clearance to a wearable device—with a form factor you’re familiar with—that can check patients ...
Business Insider3d
Abeona Therapeutics® Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa
CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA ... collagen VII protein which is needed to form ...
CBS News8d
FDA to pull common but ineffective cold medicine from market
The Food and Drug Administration announced Wednesday that it would seek to pull a widely used ingredient in cough and cold medicines from the market, after the agency's scientists concluded that ...
The Hill9d
RFK Jr. says ‘entire departments’ at FDA ‘have to go’
Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire departments” within the Food and Drug Administration (FDA) that ...
ANI Pharmaceuticals Reports Record Third Quarter 2024 Financial Results and Raises 2024 Guidance
Generated record quarterly net revenues of $148.3 million, representing year-over-year growth of 12.5%, and record Purified Cortrophin® Gel net ...
manilatimes7d
Ocugen Provides Business Update with Third Quarter 2024 Financial Results
Over a series of conferences during the third quarter 2024, Ocugen had the opportunity to provide an update on its three ...
USA Today29d
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday. The regulator approved Vyalev, also known as ...
Monthly Prescribing Reference23d
Antidepressant Recalled Due to Presence of Nitrosamine Impurity
The FDA has designated this a Class II recall. Over 7100 bottles of duloxetine have been recalled due to the presence of a nitrosamine impurity, N-nitroso-duloxetine, according to the Food and ...
Reuters24d
US FDA approves Pfizer's RSV vaccine for adults at increased risk of the disease
Oct 22 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Pfizer's (PFE.N), opens new tab RSV vaccine for the prevention of lower respiratory tract disease caused by RSV in ...
The New York Times25d
F.D.A. Names a New Chief of Medical Devices
By Christina Jewett The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division. Dr. Tarver will face ...
Fox Business22d
McDonald's E.Coli outbreak linked to California farm, FDA investigating
The McDonald's E. Coli bacterial outbreak has been linked to a farm in California and will be investigated by the Food and Drug Administration (FDA), per reports. Taylor Farms, based in Salinas ...