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The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
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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.
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
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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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Icosavax posted positive topline interim data from its Phase I/Ib trial of IVX-121, its candidate virus-like particle vaccine against the respiratory syncytial virus in young and older adults.
Generian and Mitobridge, a wholly-owned subsidiary of Astellas Pharma, announced a collaboration to discover and develop novel small molecules for undruggable therapeutic targets.
Voting 19-2, the Vaccines and Related Biological Products Advisory Committee favored redesigning booster shots to include the coronavirus’ Omicron variant.
The Phase III study of Jazz Pharmaceuticals cannabis-derived MS Sativex failed to achieve the primary endpoint of an improvement in muscle tone in patients.
Swiss biopharma giant Novartis plans to cut up to 8,000 jobs in hopes of saving at least $1 billion by 2024.
Biogen’s Chirfi Guindo discusses the launch of the company’s next-generation approach to teaching STEM to even more students, leading to potential careers in the field.
BioSpace spoke with several Black individuals working within the life sciences to get their thoughts on the current representative disconnect and what they believe can be done to fix it.
Roivant Sciences announced it has discontinued development of several assets following a pipeline reprioritization.
Ascletis has commenced its Phase II trial in China for its candidate drug ASC22 alongside anti-retroviral therapy for the functional cure and immune restoration of HIV-1 infection.
Boehringer and BiomX intend to use the discovery platform to identify biomarkers for a pathogenic bacterium thought to be associated with IBD.