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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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Pfizer with Headlands Research plans to launch new clinical trial sites in areas that have highly diverse populations.
The FDA has a few target action dates for the end of the month, although PDUFA dates can sometimes seem like a moving target.
Life sciences organizations and companies strengthen their leadership teams and boards with these Movers & Shakers.
Zealand Pharma shared positive top-line results for its second Phase III clinical trial of its congenital hyperinsulinism (CHI) drug, dasiglucagon, in pediatric patients.
Janssen’s Tremfya, an IL-23 inhibitor, is showing an ability to separate itself from AbbVie’s Skyrizi in preventing the activation of cells that drive inflammation.
On Thursday, Mersana announced that the FDA granted an orphan drug designation to one of its lead assets, XMT-2056, which is intended to treat gastric cancer.
On Wednesday evening, a man in Massachusetts became the first person reported to have a case of monkeypox in the U.S. The man contracted monkeypox after traveling to Canada.
As the American Society of Gene & Cell Therapy’s 25th Annual Meeting wraps up, a host of life science companies touted their research and products. BioSpace looks at some of them.
Pfizer, Sarepta Therapeutics, Genethon and Solid Biosciences are working on gene therapies for Duchenne Muscular Dystrophy. Now, the four companies have teamed up.
U.K. researchers found that the first dose of any vaccine was linked with an initial 12.8% decrease in the odds of Long COVID.