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 ...

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

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.

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.

The Global Coalition for Adaptive Research (GCAR) has executed an agreement to evaluate AstraZeneca's AZD1390 compound in the ...

(Alliance News) - GSK PLC said on Monday that the US Food & Drug Administration accepted a biologics license application for its Blenrep combinations for the treatment of relapsed and refractory ...