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

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

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

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

The FDA's generative AI, Elsa, has a massive hallucination problem, according to the agency's employees themselves.

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

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 ...

Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...

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

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