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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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Moderna may seek the FDA’s accelerated approval for its personalized cancer vaccine, president Stephen Hoge said Monday.
The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday.
With the results from the CLEAR outcomes study, Esperion is poised for a major inflection in sales and is targeting blockbuster status, said CEO Sheldon Koenig on an investor call Monday.
Here are some tips to help you nail virtual interviews and networking events so you can be prepared for BioSpace’s Virtual Talent Connect on March 9.
Incyte Corporation’s Phase III LIMBER-304 clinical trial has come to an end following a third-party investigation that forecasted poor results.
Voyager Therapeutics unlocked a potential $600 million plus $25 million upfront as Novartis exercised its option to leverage the company’s capsids against two undisclosed neurologic disease targets.
The FDA’s Oncologic Drugs Advisory Committee will meet March 9 to discuss Roche’s sBLA for Polivy in first-line DLBCL, while Acadia awaits potential approval of the first therapy for Rett Syndrome.
Shares of Praxis Precision Medicines dropped 48% Friday morning following mixed Phase II results for ulixacaltamide (PRAX-944), its candidate being studied in movement disorder essential tremor.
Sen. Bernie Sanders (I-VT), chairman of the Senate’s Health, Education, Labor and Pensions Committee, sent a letter to Sanofi and Novo Nordisk urging them to lower insulin prices.
Phase III data showed the combination of Roche’s Tecentriq and Exelixis’ Cabometyx fell short of its primary endpoint in renal cell carcinoma.