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 ...
FierceBiotech27m
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 ...
BioSpace1h
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 ...
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 ...
MassDevice1h
Siemens Healthineers wins FDA nod for heart-attack-predicting test
Siemens Healthineers says a new FDA clearance will advance the care of people at risk of heart attacks in the United States.
MassDevice32m
Gradient adds former Edwards exec to board as FDA approves trial expansion
Gradient Denervation Technologies announced today that it appointed medical device entrepreneur and executive Stanton Rowe to ...
ENDPOINTS NEWS3h
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 ...
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 ...
News 6 WKMG11m
Local surgeon gives insight to new FDA guidelines for mammograms
New updates to mammogram guidelines from the FDA can help determine how how often you need one as well as the types of tests ...
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FDA Approval of Trodelvy Withdrawn for Urothelial Carcinoma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 ...
Newsweek22h
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 ...