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After overcoming a clinical hold, Astellas presented preliminary safety and efficacy data from the Phase I/II FORTIS trial of AT845 in late-onset Pompe disease at the 19th Annual WORLDSymposium 2023.
Artificial intelligence and machine learning could change the face of cancer diagnostics. BioSpace spoke with the University of Waterloo, Gina Life and OncoHost to find out how.
The FDA accepted the BLA for and granted Pfizer’s maternal RSV vaccine candidate priority review.
Akebia Therapeutics announced another delay Tuesday in a series of setbacks for vadadustat, being developed to treat anemia linked to chronic kidney disease.
Actinium Pharmaceuticals’ Iomab-B met the primary endpoint in the Phase III SIERRA trial, demonstrating durable Complete Remission at six months.
Many researchers have found it necessary to transition from academia to industry to bring their therapeutic visions to fruition, but this change can be quite the culture shock.
On Friday, the FDA approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) as the first treatment for geographic atrophy (GA), a leading cause of blindness.
Takeda’s vedolizumab met its primary endpoint in the Phase III GRAPHITE study, significantly improving event-free survival in patients with acute graft-versus-host disease.
Hemab Therapeutics announced the closing of an oversubscribed Series B round to bring new treatment options for lesser-known bleeding disorders.
The FDA granted accelerated approval Friday to Travere Therapeutics’ sparsentan, now to be marketed as Filspari, to reduce the burden of proteinuria in adults with primary IgA nephropathy.
If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
Moderna announced mixed interim results Thursday from a Phase III trial of mRNA seasonal flu vaccine candidate, mRNA-1010.
Pfizer and Valneva are dropping approximately half of enrolled participants in the Phase III VALOR study for their Lyme disease vaccine candidate, VLA15.
One-year data from a Phase II study of Newron’s schizophrenia candidate evenamide showed sustained efficacy and continued improvements in symptoms of psychosis and disease severity.
Seagen did not address rumors of a buyout from Merck during its fourth-quarter and full-year financial report. Instead, it focused on upcoming label expansions and its promising pipeline.
Talaris Therapeutics is cutting one-third of its workforce and dropping two clinical trials studying its lead candidate.
Aera Therapeutics emerged from stealth mode Thursday with a platform based on the work of Feng Zhang, Ph.D. and ex-Alnylam executive Akin Akinc at the helm.
Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has appointed Dr. Deborah Charych to its board of directors effective immediately.
Taxpayer-funded research in biosciences will no longer sit behind paywalls. Instead, all of this data will be publicly available for no cost.
Spanish drugmaker Grifols announced a comprehensive plan Wednesday to improve its efficiency and cost-effectiveness – a move that will reportedly cost some 2,000 U.S. jobs.