The sBLA submission included results from the randomized, parallel-arm, placebo-controlled and active-controlled trial foresiGHt.

Checkpoint said in July that the FDA accepted for review its resubmission of the Biologics License Application for the drug and set a Prescription Drug User Fee Act goal date of Dec. 28. Shares were ...

Ascendis Pharma (ASND) announced that the FDA has accepted for review its supplemental biologics license application, or sBLA, in adult growth ...

Shares of Checkpoint Therapeutics rose 4.6% to $3.84 in post-market trading after the Food and Drug Administration approved Unloxcyt (cosibelimab-ipdl) for advanced cutaneous squamous cell carcinoma, ...

Full NORSE EIGHT Data Readout Expected January 2025ISELIN, N.J., Dec. 13, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union ...

Outlook Therapeutics (OTLK) announced that following an internal strategic review, the management team and board of directors have implemented ...

Candel shares are moving lower on Friday after the company priced its $80 million underwritten public offering of shares and ...

The FDA has accepted for review the BLA for mepolizumab as an add-on maintenance treatment for eosinophilic COPD.

Medicare drug price negotiation could have significant impacts on investment in post-approval studies for cancer treatment ...

Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused ...

UniQure (QURE) stock shot up 90% on news the company had reached an agreement with the FDA on an accelerated approval pathway ...

The risk for disease progression or death was reduced by 51% with subcutaneous Darzalex Faspro in certain patients with ...