STAT7m
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 ...
MLive5h
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 ...
FDA issues recall for antidepressant drug
The Federal Drug Administration issued a recall on Tuesday for a common medicine for depression. Over 7,000 bottles of ...
Antidepressant recalled: 2nd-highest FDA risk level; drug contains cancerous chemical
The U.S. Food and Drug Administration updated the risk level of a recalled antidepressant due to the product containing high ...
STAT6h
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 ...
MassDevice3h
iRhythm stock soars on 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 ...
FierceBiotech7h
Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package
The biotech engaged with the FDA on alternative pathways to approval after seeing safety and efficacy data from the phase 1/2 ...
BioPharma Dive2h
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 News6h
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 ...
MassDevice4h
FDA clears Gentuity imaging system for coronary interventions
Gentuity announced today that it received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging ...