BioSpace News Archive

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab

AVEO Oncology today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC).

Salarius Pharmaceuticals, Inc. today announced its inclusion in the FTSE Global Micro Cap Index. Salarius’ inclusion in the FTSE index will be effective after the U.S. market opens today, Monday, September 20, 2021.

Rhythm Pharmaceuticals, Inc. today announced that it has completed its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMCIVREE ®

BeyondSpring today will have a late-breaking oral presentation at the European Society for Medical Oncology 2021 Congress.

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing LUCENTIS® (ranibizumab)i for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

New In Vivo Data Also Show Sustained Knockdown of Toxic Human Nuclear DMPK RNA and Foci Reduction - - DM1 Program is One of Three IND Submissions Planned Between the Fourth Quarter of 2021 and the Fourth Quarter of 2022

TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL).

Cyteir Therapeutics, Inc. was added as a member of the U.S. small-cap Russell 2000® Index, effective after the US market opens on September 20, as part of the 2021 Russell indexes reconstitution.

Marinus Pharmaceuticals, Inc today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company’s New Drug Application (NDA) for the use of ganaxolone in the treatment of seizures