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Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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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.
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.