The selection comes more than 18 months after the application period closed in April 2023 ... OK with operating in the ...

At least some of the losing applicants are expected to challenge the health agency’s decisions and lead to further delays.

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 ...

In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA) ...

Theratechnologies (THTX) announced the resubmission of its supplemental Biologics License Application, sBLA, to the U.S. Food and Drug ...

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.

4,5 The drug’s efficacy and safety were never in question. The biologics license application was originally accepted by the ...