The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...

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

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

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 ...

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 ...

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

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that ...

A Food and Drug Administration (FDA) expert panel has reignited a debate over whether hormone therapy should be used to treat ...

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...

Replimune shares collapsed on Tuesday after the U.S. Food and Drug Administration rejected the clinical-stage biotechnology company's proposed advanced melanoma treatment. Shares of the Woburn, Mass., ...