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BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
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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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Read our takes on the biggest stories happening in the industry.
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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Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressed—and there’s more to come in 2026.
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.
Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
Following the successful late-stage study in wet age-related macular degeneration, Ocular plans to meet with the FDA to determine a regulatory path for Axpaxli.
Johns Hopkins’ Thomas Hartung discusses how drug discovery and development will change under evolving regulatory policies that embrace AI technology as well as organoid and other non-animal models of human biology.
The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.