Optune Pax concomitant with gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic...
Approval expands PD-L1 testing to support treatment decisions with KEYTRUDA® (pembrolizumab)1, 2 Agilent Technologies Inc. announced ...
Trace Biosciences, Inc., a clinical-stage biotechnology company developing nerve-targeted imaging agents, announced that the U.S. Food and Drug Adm...
BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneo...
If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing fo...
Alveus Therapeutics, Inc. (“Alveus”), a clinical-stage biotechnology company developing next-generation therapies for obesity and metabolic d...
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA...
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced that the Company has decided to voluntarily withdraw the biologics...
This further establishes the global leadership of AGC Biologics' Milan Cell and Gene Center of Excellence in number of commercial products approved ...
30,000-Square-Foot Facility Will Advance America's Priority to Reshore Essential Drug Manufacturing Apiject Holdings, Inc. announced the signing of a le...
Designation further supports (Z)-Endoxifen program into rare pediatric neuromuscular disease along with previously received Rare Pedi...
Santhera Pharmaceuticals (SIX: SANN) announces that the Swiss Agency for Therapeutic Products (Swissmedic), has approved AGAMREE® (vamorolone) for th...
Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ® BYOOVIZ becomes the fourth biosimi...
Axsome Biotherapeutics announced that the US regulator has granted Priority Review to its investigational therapy for agitation associated with Alzheimer...
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