US FDA declines to approve Camurus' rare hormone disorder drug
The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...
ENDPOINTS NEWS1h
FDA hits Ca­mu­rus with CRL for acromegaly ther­a­py over man­u­fac­tur­ing is­sues
The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at ...
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 ...
biopharma-reporter2h
FDA approves targeted therapy for gastric cancer and its companion diagnostic
The FDA has simultaneously granted approval to Astellas’ cancer drug Vyloy and to a companion diagnostic test developed by ...
SeafoodSource2h
FDA issues warning letters to Spanish, Venezuelan seafood importers for safety risks
The U.S. Food and Drug Administration (FDA) has issued warning letters to Spain’s Bacalao Giraldo and Venezuela’s Procesadora ...
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 ...
STAT1d
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 ...
Newsweek19h
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 ...
MassDevice15h
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 ...
FierceBiotech23h
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 ...
BlackDoctor19h
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 ...
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 ...