MLive4h
7,100 bottles of antidepressant recalled by FDA now in 2nd highest risk class
Duloxetine Delayed-Release Capsules were recalled because the pills may contain high levels of a cancer-causing chemical.
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 ...
STAT2h
Novo asks FDA to bar compounders from making Ozempic copies
The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable ...
BioPharma Dive4h
FDA names Tarver as new head of device center
Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.
Convenience Store News8h
FDA Seizes 3 Million Unauthorized E-Cigarettes in Joint Federal Operation
The Food and Drug Administration, in collaboration with the U.S. Customs and Border Protection (CBP), seized about three ...
STAT8h
Michelle Tarver to lead FDA medical device center
Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an ...
The Fence Post5h
FDA: Be ready to comply on food traceability
Food companies should be ready to comply with the Food Safety Modernization Act Food Traceability Final Rule on Jan. 20, 2026 ...
FiercePharma12h
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 ...
BioSpace12h
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 ...
MassDevice6h
FDA’s Dr. Michelle Tarver officially becomes new CDRH director
The FDA has removed the "acting" from Dr. Michelle Tarver's title as head of the Center for Devices and Radiological Health ...