FDA warns of scramble for workspaces and parking spots in Monday return to office
In Thursday's meeting, the director of the FDA's Center for Drug Evaluation and Research said plans for coming layoffs were ...
US FDA expands approval for Alnylam's drug to treat rare heart disease
U.S. Food and Drug Administration approved Alnylam's drug to treat a rare and deadly heart disease on Thursday, allowing the ...
FDA warns consumers to avoid inhaling nitrous oxide products after noting increase in reported abuse
The FDA said inhaling nitrous oxide can result in a range of symptoms and serious health problems, including lightheadedness, ...
Nearly a third of FDA medical device adverse events reported late: study
Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.
The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...
ABC News10d
Compound versions of some weight loss drugs to be restricted
ABC News chief medical correspondent Dr. Tara Narula said Tuesday on "Good Morning America" that the FDA's decision to halt ... risk of major cardiovascular events in adults with obesity or ...
Yahoo Finance9d
Nearly a third of FDA medical device adverse event reports filed late
Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period ...
KOAT Albuquerque11d
What to know after FDA canceled event on next flu vaccine
SMOKING. THE FDA RECENTLY ANNOUNCED IT’S CANCELING AN UPCOMING MEETING TO DISCUSS NEXT YEAR’S FLU VACCINE. KOAT SEVEN MEDICAL EXPERT DOCTOR BARRY RAMOS SAYS THIS COULD BE DANGEROUS FOR THE FLU. VIRUS ...
Seeking Alpha7d
Nearly a third of FDA medical device adverse events reported late: study
Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most late reports filed more than six months after manufacturer notifications ...
Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...
Novartis2d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...