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.

A Mayo Clinic study confirmed the accuracy of a new FDA-approved blood test for early detection of Alzheimer's disease.

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 ...

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

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

Savara faces an FDA setback for Molbreevi, its aPAP treatment. Learn how the company plans to recover and file a new BLA by ...

USFDA issued a warning letter to Glenmark Pharmaceuticals for significant CGMP violations at its Pithampur plant, including failing to establish laboratory controls and adequate testing programs.

Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...

The US health regulator has pulled up Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish laboratory controls, at its Pithampur-based plant.      In a warning letter, the ...

Replimune Group, Inc. (NASDAQ:REPL) saw its stock nosedive 77% on Tuesday after the company revealed it received a Complete ...

The Senate has given final approval to President Donald Trump’s pick to run the Drug Enforcement Administration (DEA)—and a ...