The Norse Eight trial was part of the data requested by the FDA after the agency rejected the BLA for the company’s Lytenava ...

Outlook Therapeutics (OTLK) announced preliminary topline results of Norse Eight, the second of two adequate and well controlled clinical ...

Outlook Therapeutics will resubmit a biologics license application for its ophthalmic formulation of bevacizumab early next year after the second of two clinical trials missed a key target. The ...

Final efficacy data expected in January 2025Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J., Nov. 27, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: OTLK), a biopharmaceutical company that ...

SPRING HOUSE, PA – Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a subcutaneous ...

The FDA has received a biologics license application submission for RP1 plus nivolumab in patients with PD-1 ...

Theratechnologies (NASDAQ:THTX) has resubmitted its supplemental Biologics License Application for a simplified dosing formulation of its drug tesamorelin for the reduction of excess abdominal fat in ...

The approval is supported by data from the COBLT study, FDA dockets and public information, and an observational database.

London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License ...

MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced ...

Theratechnologies (TSE:TH) has released an update. Don't Miss our Black Friday Offers: Theratechnologies has resubmitted a supplemental Biologics License Application to the FDA for its F8 formulation ...