centerforbiosimilars1d
FDA Reviews Golimumab Biosimilar, Samsung Biologics Hits Record Sales, Japan Approves Stelara Biosimilar
The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese ...
Scholar Rock: More Than Just An SMA Biotech With Q2 2025 Obesity Treatment Data
Scholar Rock submitted its BLA of apitegromab for the treatment of patients with Spinal Muscular Atrophy with a request for ...
Scholar Rock submits FDA application for SMA treatment
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, ...
FDA accepts Teva, Alvotech BLAs for Simponi biosimilars
The FDA has accepted Alvotech (ALVO) and Teva's (TEVA) applications for AVT05, their proposed biosimilar to J&J's ...
Alvotech, Teva announce FDA accepts BLA for AVT05
Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the U.S. FDA has ...
FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing
Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License ...
Hosted on MSN9d
REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA
Replimune Group, Inc. REPL announced that the FDA has accepted the biologics license application (BLA) for its lead pipeline ...
Targeted Oncology15d
FDA Issues Complete Response Letter for Tab-cel in EBV+ PTLD
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 ...
JCN Newswire16d
FDA Accepts LEQEMBI (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's 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 ...
Yahoo Finance17d
FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
STOCKHOLM, Jan. 14, 2025 /PRNewswire/ --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 ...
Sharecast17d
FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosingLeqembi is indicated for the treatment of ...