The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable ...

The U.S. Food and Drug Administration on Tuesday approved Pfizer's RSV vaccine for the prevention of lower respiratory tract ...

Abrysvo can prevent lower respiratory tract disease caused by RSV for people between the ages of 18 and 59 who are at ...

Duloxetine Delayed-Release Capsules were recalled because the pills may contain high levels of a cancer-causing chemical.

Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.

Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an ...

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 ...

The FDA issued a complete response letter (CRL) to Camurus, dealing a setback to the Swedish drugmaker’s efforts to bring its ...

Lykos Therapeutics may have shed three-quarters of its staff in the wake of the FDA's rejection of its MDMA candidate for ...

The U.S. Food and Drug Administration (FDA) has issued warning letters to Spain’s Bacalao Giraldo and Venezuela’s Procesadora ...

The U.S. Food and Drug Administration is urging patients not to stop taking their prescribed medication if it falls under the ...

Sangamo (SGMO) announced the outcome of a recent interaction with the FDA, providing a clear regulatory pathway to accelerated approval for ...