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 ...
STAT3h
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 ...
MassDevice6h
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 ...
BioPharma Dive5h
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.
STAT9h
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 ...
Convenience Store News9h
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 ...
FiercePharma13h
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 ...
FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...
MassDevice7h
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 ...