The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese ...

CAMBRIDGE, Mass. - Scholar Rock (NASDAQ: SRRK), a biopharmaceutical company with a market capitalization of $3.96 billion and an impressive 362.73% stock price surge over the past six months, ...

The FDA has accepted Alvotech (ALVO) and Teva's (TEVA) applications for AVT05, their proposed biosimilar to J&J's ...

The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...

Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the U.S. FDA has ...

Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License ...

The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the ...

The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.

LO7: Develop communication skills in the form of report and essay writing. LO1: Demonstrate knowledge and understanding of the chemistry of life and its application to biological sciences. LO2: ...

The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for Epstein-Barr virus–positive post-transplant lymphoproliferative disease ...

TOKYO and CAMBRIDGE, Mass., Jan 15, 2025 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License ...