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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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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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The FDA is asking Eli Lilly to submit cardiovascular and liver safety data from an ongoing Phase 3 trial of Foundayo by July.
Johnson and Johnson kicked off first-quarter earnings season with a “modest” beat and an ambitious goal; Replimune failed again to gain approval for its advanced melanoma therapy, as analysts tout increased accountability brought by the FDA’s new policy of publicizing complete response letters; and Revolution Medicines’ pancreatic cancer candidate doubled survival in one of cancer’s most intractable foes.
Amidst rising layoffs in key biotech hubs, global demand for specialized life sciences talent is driving a more borderless, distributed model of scientific work.
Gilead, AstraZeneca and Vertex have acquired more than just a therapeutic asset in recent deals. BioSpace takes a look at five recent transactions where the staff was the real centerpiece.
BioSpace looks back at 2025 and where the FDA is going in 2026.
The draft guidance supports the agency’s new pathway designed to speed up the development of custom gene therapies.
By closing the Universal Cells Seattle location, Astellas is reportedly consolidating cell therapy, gene therapy and oncology research at its South San Francisco, California, and Westborough, Massachusetts, sites.
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q1 job market performance and what it signals for the coming months.
With robust sales performance from oncology darling Darzalex and immunology superstar Tremfya, Johnson & Johnson is “off to a fast start in 2026,” CEO Joaquin Duato told investors on Tuesday.
With many overseas patients preferring orals to injectables, Eli Lilly has filed for approval of orforglipron in more than 40 countries and is building manufacturing capacity to support the obesity drug.