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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 FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.
Of the 11 companies participating in the spring cohorts of the Drive program run by MassBio and SCbio, eight have locations in Massachusetts. One cohort focuses on biotech and the other on biomarkers and diagnostics.
Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors.
While peptides are currently the dominant approach to GLP-1 agonism, Ambrosia Biosciences is pursuing a small-molecule approach.
The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile. The pharma refused.
The FDA advised IO Biotech last year to hold off on filing an approval application for its cancer vaccine Cylembio, pointing to a failed Phase 3 study in frontline advanced melanoma. The biotech has now gone under.
As AI reshapes deeply specialized scientific work, R&D professionals must learn to navigate the shift to a skills-centered market. The key is knowing which skills to develop and how to leverage AI as scientific modalities evolve, technologies advance and regulatory complexity increases.
Convergent Therapeutics’ Dr. Philip Kantoff and Plus Therapeutics’ Dr. Marc Hedrick discuss how unmet medical needs, maturing isotope supply chains and innovative delivery are positioning targeted radiation as oncology’s next big platform.
Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?
The recent uptick in IPOs is an encouraging signal after a drought for much of 2025. Experts point to AI as a driving force behind this resurgence.