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Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeuticsâ 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 Medicinesâ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotechâs heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerabilityâand more time for patients.
The recent approval of Regeneronâs 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 divisionsâthe CDC and the FDAâs two primary review units.
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Seven biotech unicorns are advancing AI-powered drug discovery and developmentâbut must contend with a difficult investing environment where competition is steep and the usual roads to exit are uncertain.
In this bonus episode, BioSpaceâs Vice President of Marketing â Chantal Dresnerâ and Careers Editor â Angela Gabrielâ take a look at Q2 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump administration could move forward with its sweeping reorganization of the agency.
HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval.
According to Makary, reducing user feesâwhich make up just under half of the FDAâs budgetâcould make it easier for smaller companies, individual investors and academics to participate in the process.
The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application in China and global clinical trials.
More than thirty years since its 1993 founding, Catherine Owen Adams and Elizabeth Thompsonâthe R&D combo that has led Acadia since last yearâare managing two products on the market and a pipeline estimated to be worth an additional $12 billion in sales.
Despite the FDA commissionerâs promises of partnership and collaboration, personnel changes and continued federal cuts create uncertainty for an industry already struggling with nearly half a decade of investment scarcity.
The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its cardiovascular and kidney disease pipelines.
Takedaâs oveporexton improved wakefulness, attention and other key narcolepsy endpoints âwith a high degree of statistical significance,â according to Jefferies analysts.