Antidepressant recall: FDA upgrades medication risk class to 2nd highest level in recall update
The U.S. Food and Drug Administration is urging patients not to stop taking their prescribed medication if it falls under the ...
Amid backlash, FDA changes course over shortage of weight-loss drugs
The FDA said Eli Lilly’s weight-loss drugs were no longer in shortage on Oct. 2, preventing pharmacies from making cheaper ...
STAT23h
Former FDA lawyers join tobacco industry in ‘epic’ fight against the agency
Gorji joined DLA Piper, one of the biggest law firms in the world, as a litigation partner, adding to its FDA team, which ...
Newsweek15h
Milk Recall Update As FDA Sets Highest Risk Level
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for a line of milk products as they may contain undeclared almonds from almond milk, a known allergen. The firm-initiated recall ...
FierceBiotech19h
Lykos accepts FDA’s view that reviving rejected MDMA therapy’s fortunes requires fresh phase 3 trial
Lykos Therapeutics may have shed three-quarters of its staff in the wake of the FDA's rejection of its MDMA candidate for ...
MassDevice11h
iRhythm earns FDA nod for changes to Zio AT following warning letter
Rhythm Technologies (Nasdaq:IRTC) announced today that it received FDA 510(k) clearance related to design changes made to its ...
Targeted Oncology13h
FDA Accepts NDA Resubmission of Rivoceranib and Camrelizumab in HCC
The new drug application resubmission of rivoceranib/camrelizumab in the first line in unresectable or metastatic ...
Listeria contamination prompts recall of generic waffle brands at retailers across U.S., FDA says
Generic waffle brands at retailers across the U.S. are being recalled after listeria, a potentially fatal bacterial disease, ...
Nationwide Antidepressant Recall Update As FDA Sets Risk Class
On October 11, the recall was classified as a class II recall by the FDA—a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health ...
BlackDoctor15h
Is the FDA Making the Right Moves on Clinical Trials?
The FDA announced new provisions that require sponsors to submit Diversity Action Plans. But what does that mean for the ...
Becker's Hospital Review16h
FDA retreats from declaring end to Mounjaro shortage
In a reversal, the FDA is reconsidering its decision to end the shortage status of tirzepatide, after a recent lawsuit and intense public pressure, The Washington Post reported Oct. 21.
FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...