Latest News
& Press Releases
Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-2 against Oncopeptides’ Pepaxto, a drug that has been on the market since 2021 for multiple myeloma under accelerated approval.
The FDA will meet Friday to discuss the future of Secura Bio’s Copiktra (duvelisib), which has been approved as a third-line treatment for relapsed or refractory CLL/SLL.
This week, researchers delivered insights and breakthroughs in regenerative medicine, Long COVID, immuno-oncology and inflammatory diseases.
Merck announced positive results on its patent infringement case against Viatris, while Amgen faces political headwinds from the White House.
One-year data indicates Biogen’s tofersen for SOD1-ALS, slows the decline of the disease through the lowering of SOD1 protein and neurofilament levels.
AstraZeneca has decided to drop the hypercholesterolemia candidate AZD8233 through to Phase III, despite meeting its Phase IIb primary efficacy endpoint, its partner Ionis announced Friday.
The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.
Advances in immuno-oncology and adaptive cell therapy that began about a decade ago are enabling fresh, biology-driven approaches to bring therapeutic cancer vaccines closer to fruition.
Seven biopharma companies are under new leadership. This week’s Movers & Shakers highlights these new chief executive officers who aim to guide their companies into the future.
Novartis outlined how its transformation to a pure-play innovative medicines company is nearly completed during a “Meet the Management” event in Switzerland.
The 7th Annual CAR-TCR Summit is ongoing in Boston, with more than 1,000 experts in CAR and TCR technologies attending. Here’s a look at some of the latest research and data being presented.
Alaunos Therapeutics, Satsuma Pharmaceuticals, NeuroSense, Emyria and more reported updates in solid tumors, migraine, ALS and MDMA drug discovery.
PRESS RELEASES
Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access
Highlights TempraMed signs non-binding LOI for exclusive distribution in Kuwait with Elegir Trading Kuwait represents a high-value market with significant demand for insulin, GLP-1 therapies, biologics, and other temperature-sensitive medications LOI includes minimum annual purchase commitments in Year 1 Expands TempraMed’s footprint across the Middle East and supports broader regional commercialization strategy Potential future expansion includes VIVI Med™, VIVI Epi™, and VIVI Cap Smart™ products
— Veteran Physician-Scientist Brings Over 25 Years of Pulmonary and Cardiopulmonary Clinical Development Leadership Spanning Pfizer, Gilead, and Aerovate Therapeutics —