Replimune's BLA submission and promising pipeline drugs are set to impact the global melanoma therapeutics market. Read more ...

Outlook said it remains confident that ONS-5010, marketed as Lytenava in the EU, is an important therapy for the treatment of wet age-related macular degeneration in place of off-label repackaged ...

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) ...

SPRING HOUSE, PA – Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S ...

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.

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.

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 ...