Drug Approval | March 13, 2026
Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Marks significant milestone for breakthrough biologic to treat rare blood cancers
Marks significant milestone for breakthrough biologic to treat rare blood cancers
The collaboration will leverage this clinical experience to inform NCEL-101 development, streamline regulatory pathways, and potentially accelerate timelines for achieving durable graft survival comparable to donor human islets
The study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
ABBV-295 produced clinically meaningful, dose-dependent weight loss over 12–13 weeks
This study evaluated a difficult-to-treat Crohn's disease patient population
AA, a chronic immune disease, can cause extensive and unpredictable hair loss
The program offers selected participants advanced access to Promise Bio’s broad-epiproteomic platform
Investment marks continued progress against AbbVie's $100 billion commitment to U.S. R&D and capital investments, including manufacturing, over the next decade
Merck is currently conducting approximately 80 Phase 3 studies, and the company expects more than 20 new growth drivers over next several years, almost all with blockbuster potential
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