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, ...

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.

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 ...

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

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 ...

Ascendis Pharma announced that the FDA has accepted their supplemental Biologics License Application for TransCon hGH in treating adult growth hormone deficiency. The decision marks a significant step ...

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.