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) ...

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 ...

GSK plc GSK announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep ...

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

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 ...

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

The FDA has accepted for review the resubmitted sBLA for dupilumab for the treatment of chronic spontaneous urticaria.

Asimov, the synthetic biology company advancing the design and manufacture of therapeutics, today announced a licensing agreement for its CHO Edge System with RevOpsis Therapeutics ("RevOpsis"), a nex ...