Purple Biotech Ltd. ('Purple Biotech' or 'the Company') (NASDAQ/TASE: PPBT), a clinical-stage company developing ...

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 ...

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

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...

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

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

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., ...

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

Investing.com -- Replimune Group, Inc. (NASDAQ: REPL) stock plunged 77% after the company announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) ...

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...

The Senate has given initial approval for the chamber to take up the confirmation of President Donald Trump’s pick for head of the Drug Enforcement Administration (DEA)—a choice that will likely ...