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

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

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

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

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

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

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

Shares fell 75% to $3.04, putting the stock on track for a record closing low, according to Dow Jones Market Data. The stock ...

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

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's drug ...

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