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FDA Grants Orphan Drug Status to Immutep’s Efti for Soft Tissue Sarcoma

The rare-disease status positions efti for regulatory support in a potential neoadjuvant sarcoma study.

FDA Rejects Replimune’s Melanoma Virus Therapy Again for Insufficient Evidence

Ocugen Completes Phase III Enrollment for OCU400 and Targets Q3 2026 Rolling BLA

Can-Fite's Namodenoson Clears Phase IIa Safety Bar in Pancreatic Cancer

Wall Street Sees 175% Upside for Viking Therapeutics on Obesity Drug Bet

AnaptysBio Seeks to Toss Tesaro Anticipatory‑Breach Claim in Jemperli Royalty Dispute

FDA Grants Priority Review to Vera's Atacicept for IgA Nephropathy

Final Phase I Data Show Preventive TNBC Vaccine Is Safe and Induces Immune Responses in Most Participants

MoonLake Faces Expanding Securities Suits as Lead-Plaintiff Deadline Nears

Dyne’s DMD Drug Hits Primary Endpoint in DELIVER REC, Shows Functional Gains

MoonLake Investors Courted by Law Firms as Lead‑Plaintiff Deadline Nears in SDNY Securities Case

AnaptysBio and GSK’s Tesaro File Dueling Suits Over Jemperli License and Royalties

MoonLake Investors Get Deadline Reminder as Securities Suits Mount Over Sonelokimab Trial

MoonLake Investors Face Dec. 15 Lead-Plaintiff Deadline as Securities Case Advances in SDNY

MoonLake Investors Face Dec. 15 Lead-Plaintiff Deadline in SDNY Securities Case

Replimune Reports No Defined Accelerated-Approval Path After FDA Type A Meeting on RP1 for Melanoma