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

Scholar Rock submitted its BLA of apitegromab for the treatment of patients with Spinal Muscular Atrophy with a request for ...

Alvotech and Teva announced FDA acceptance of the Biologics License Application (BLA) for AVT05, a proposed biosimilar ...

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

INDICATION LEQEMBI ® [ (lecanemab-irmb) 100 mg/mL injection for intravenous use] is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with ...

The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22 ...

Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has ...

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 ...

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: ...

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 ...