Checkpoint said in July the FDA accepted for review its resubmission of the Biologics License Application and set a Prescription Drug User Fee Act goal date of Dec. 28. The agency issued a Complete ...

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 ...

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

Separately, upon receipt of the full efficacy and safety results for the NORSE EIGHT clinical trial in the United States, which are expected in January 2025, Outlook Therapeutics plans to resubmit its ...

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

Candel intends to use the net proceeds from the offering to continue the development of our product candidates, including preparing the submission of a Biologics License Application for CAN-2409 in ...

Ascendis Pharma (ASND) said the FDA has accepted for its supplemental Biologics License Application for TransCon hGH for the treatment of adult growth hormone deficiency, or GHD. The agency has set a ...

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

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

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

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

The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the ...