The federal agency introduced Elsa last month, boasting about the AI tool's ability to increase efficiency at the FDA.

Moderna stock rises on flu vaccine data and FDA approvals, while healthcare stocks remain under pressure amid political ...

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...

When the U.S. Food and Drug Administration (FDA) convened a public expert panel to review the use of selective serotonin ...

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

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

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

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

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

FDA fast-tracks DB-1310, a novel HER3-targeting ADC, offering hope for advanced NSCLC patients with unmet treatment needs.

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., ...