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The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
September 24 is World Cancer Research Day, and September is Childhood Cancer Awareness Month. BioSpace spoke with leaders from three companies tackling pediatric glioma.
Recently published research into repairing nerve damage caused by injury may also pay off in treating some of the most vexing neurodegenerative diseases like Alzheimer’s.
NovoCure announced the launching of a U.S.-based arm to focus on and attempt to grow its glioblastoma (GBM) business and increase its patient population.
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.
Allogene Therapeutics’ French partner Servier has withdrawn all involvement in the development of Allogene’s anti-CD19 products, allowing Allogene to license its CD19 products outside the U.S.
Shares of Spero Therapeutics soared in premarket trading following GlaxoSmithKline’s announcement that it will license the company’s late-stage antibiotic asset, tebipenem HBr.
New data from Novo Nordisk’s Phase IIIa ONWARD 2 trial studying insulin icodec shows it is effective as a once-weekly treatment for Type 2 diabetes.
Several biotech companies backed by billions are working on different approaches to developing the next big anti-aging therapy - from blood experiments to cell reprogramming.