Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

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

Months after the FDA approved three natural food additives, it's added another to the list. Experts share what parent should ...

FDA issues a complete response letter for glofitamab's second-line DLBCL indication, highlighting ongoing scrutiny in ...

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

Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.

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 ...

Ultragenyx's UX111 gene therapy faces FDA delay due to facility issues; analysts adjust price targets amid uncertain ...

Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...