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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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The FDA approved Braeburn Pharmaceuticals’ new buprenorphine treatment option with extended-release medication that could pave the way for greater patient compliance.
Autistic employees bring a uniquely valuable skill set to the life sciences workplace, but it’s on the employers to provide the support they need.
Wave will discontinue development of WVE-004 in C9-associated ALS and frontotemporal dementia after the therapy failed to show any clinical benefit in a mid-stage trial.
The regulator approved Xacduro for treating hospital-acquired and ventilator-associated bacterial pneumonia. The NDA was filed by Entasis Therapeutics, which Innoviva acquired in 2022.
Despite a disappointing showing in the Phase III MOVE-FA trial, PTC Therapeutics says it will move forward with regulatory talks for the Friedreich’s ataxia treatment. Meanwhile, the company is discontinuing several early-stage gene therapies and reducing its headcount.
While the exact settlement details are confidential, the deal will allow Amgen to launch its Stelara biosimilar no later than January 1, 2025.
The Massachusetts-based company has claimed the year’s largest fundraise so far and secured a powerhouse R&D partner in Novo Nordisk to develop gene editing medicines.
The Massachusetts-based startup’s goal is to develop RNA medicines that can treat diseases anywhere in the body using an “all-in-one” platform.
The Swiss pharma has canceled a second mid-stage trial for its investigational schizophrenia drug ralmitaront, as the competition shows promise in the space.
With the FDA’s approval on Monday, Ayvakit is the first and only treatment for adults with indolent systemic mastocytosis, a rare hematologic disorder, according to Blueprint Medicines.