Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...

Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine process.

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

FDA approves Bravecto Quantum, the first injectable flea and tick treatment offering dogs up to 12 months of protection.

WuXi Biologics secures US FDA Pre-License Inspection approval for five facilities, first for commercial PFS line: Wuxi, China Wednesday, July 23, 2025, 13:00 Hrs [IST] WuXi Biolog ...

The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older against fleas and ticks.