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 ...

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

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, ...

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

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 ...

has accepted the company’s supplemental Biologics License Application (sBLA) for Columvi ® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people ...

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

AstraZeneca (AZN) said the FDA has accepted its supplemental Biologics License Application for Imfinzi for Priority Review for the treatment of muscle-invasive bladder cancer.

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