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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 regulator has decided to hold an advisory committee meeting regarding BMS and 2seventy bio’s bid to move the CAR-T cell therapy into earlier lines of treatment, missing its previous target action date of Dec. 16.
Vorasidenib decreased tumor volume by a mean of 2.5% every six months, compared to growth of 13.9% for placebo over the same time span. The candidate is also being tested in a regimen with Keytruda.
As companies clamor for a piece of the antibody-drug conjugate pie, experts pose the question: is it possible to replicate the success of Enhertu?
Bayer’s investigational factor XIa inhibitor asundexian was inferior to BMS’ and Pfizer’s blockbuster blood thinner Eliquis (apixaban) in the Phase III OCEANIC-AF study.
Armed with a pipeline of obesity and diabetes hopefuls, Carmot Therapeutics joins the small group of biotechs to attempt a Nasdaq debut this year.
The U.K.’s conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel raises some potential safety concerns with the risk of off-target effects.
In this deep dive, BioSpace examines how small, medium and large companies are using artificial intelligence and machine learning to enhance their drug discovery efforts.
The company’s Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.
Xtandi is now approved to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis with or without a gonadotropin-releasing hormone analog therapy.
In a 12-1 tally, the FDA’s Pulmonary-Allergy Drugs Advisory Committee determined that the data does not establish a clinically meaningful benefit in this indication.