Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with advanced pulmonary arterial hypertension, according to a press release from ...

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...

Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted precision medicine strategies.

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.

GSK (GSK) stock in focus as the company secures EU approval for Blenrep combo therapies targeting the blood cancer multiple ...