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 ...
BioSpace2h
FDA Rejects Camurus’ Rare Hormonal Disorder Treatment Due to Manufacturing Problems
The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its ...
FiercePharma1h
FDA stymies Camurus' hormonal disorder drug due to 3rd-party manufacturing issues
The FDA issued a complete response letter (CRL) to Camurus, dealing a setback to the Swedish drugmaker’s efforts to bring its ...
FierceBiotech59m
FDA grants de novo clearance to airway stent covered with human tissue
The FDA has granted a de novo clearance to a new type of stent designed to hold open the passages down the windpipe and into ...
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 ...
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 ...
MassDevice23m
Peytant wins FDA de novo nod for covered stent system
Peytant Solutions announced today that the FDA granted marketing authorization for its AMStent tracheobronchial covered stent ...
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 ...
ENDPOINTS NEWS4h
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 ...
Cure Today2h
FDA Approval of Trodelvy Withdrawn for Urothelial Carcinoma
The withdrawal of the FDA accelerated approval for locally advanced or metastatic urothelial carcinoma, a type of bladder ...
MassDevice18h
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 ...
Newsweek23h
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 ...