Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application ...

Abeona Therapeutics Inc.'s promising gene therapy for RDEB, potential FDA approval, undervalued stock, and key risks. Click ...

Shares of Capricor Therapeutics CAPR gained 8.4% on Thursday following the completion of the submission of a biologics license application (BLA) to the FDA seeking full approval for deramiocel to ...

Regenxbio's rolling BLA submission completion of RGX-121 for the treatment of patients with MPS II expected in Q1 of 2025.

Eisai (ESAIY) and Biogen (BIIB) announced that the FDA has accepted Eisai’s Biologics License Application, BLA, for ...

The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...

Precigen, Inc. (NASDAQ:PGEN), a biotechnology company specializing in gene and cell therapies with a market capitalization of $398.3 million, is on the cusp of a significant transformation as it ...

BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi ...

Replimune Group Inc (NASDAQ:REPL), a biotechnology company specializing in oncolytic immunotherapy for cancer treatment, ...

The FDA has accepted the BLA for lecanemab-irmb SC for weekly maintenance dosing in the treatment of early Alzheimer disease.

Intellia Therapeutics has dosed the first subject in the Phase III trial of NTLA-2002, to treat hereditary angioedema (HAE).

The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for ...