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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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Amid rampant buyout speculation, Mirati Therapeutics reported that it will continue its final analysis of the Phase III SAPPHIRE trial following an interim survival analysis.
GSK intends to file for approval of Jemperli in endometrial cancer after the checkpoint inhibitor met its primary endpoint in the Phase III RUBY trial.
The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.
The FDA has approved Rigel’s Rezlidhia for the treatment of adults with relapsed or refractory AML with a susceptible isocitrate dehydrogenase-1 mutation.
FUJIFILM Diosynth Biotechnologies is offering unique opportunities to join one of the top global CDMOs focused on solving some of the most complex healthcare challenges.
Athira Pharma’s experimental Alzheimer’s therapy, fosgonimeton, continues to show signs of being able to improve cognition and function in patients.
Eli Lilly’s investigational antibody donanemab met all of its primary and secondary endpoints in the Phase III TRAILBLAZER-ALZ 4 study, the company announced Wednesday.
Pfizer and Roivant have joined forces to form yet another Vant. The new entity will initially work to commercialize RVT-3101 for ulcerative colitis.
SQZ Biotechnologies is slashing 60% of its workforce and looking for a new CEO after initiating a strategic prioritization to focus on its cell therapy platform for solid tumors.
PictorLabs emerged from stealth mode Thursday with $18.8 million to advance its AI-powered virtual staining platform that researchers hope will “reimagine the future” of histopathology.