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

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 ...

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.

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

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 ...

Johnson & Johnson eyes FDA nod to icotrokinra after phase III studies show strong skin clearance and safety in plaque ...