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FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.
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After years stuck in the “doldrums,” the biopharma sector is in a “very good place” heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
Pharmas will need to provide their latest stance on the Most Favored Nation drug pricing plans, while biotech finally gets a break after a few tough years.
From biotech veterans to embattled modalities to a new wave of RNAi therapeutics, BioSpace’s NextGen Class of 2026 emerged during a tough fundraising environment in 2025. Check out the 15 battle-tested companies that caught our eye.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Writing in JAMA, four former government officials warn that the Trump administration’s involvement in delaying the approval of Novavax’s COVID-19 vaccine could indicate a politicization of the drug approval processes that could ‘imperil public health.’
Are long R&D cycles, overwhelming literature reviews, or patent bottlenecks slowing your path to innovation? In the fast-evolving life science landscape, AI is no longer a luxury, it’s a necessity.
The seven new members of the CDC’s influential Advisory Committee on Immunization Practices recommended Merck’s new anti-RSV monoclonal antibody, discussed mRNA vaccine technology while injecting misinformation into the debate, heard updates on the upcoming flu season and, finally, voted to remove thimerosal from all flu vaccines.
The newly appointed members of the CDC’s influential vaccine committee meet Wednesday and Thursday under an unusually rapid timeline, with unexpected topics on the agenda.
Tapping into the hidden job market can be challenging but is important in today’s employer-driven market. Three talent acquisition experts share tips for accessing hard-to-find roles.
Eli Lilly’s tirzepatide is expected to be worth $62 billion annually by 2030, according to Evaluate. That valuation would be three times larger than what AbbVie’s blockbuster Humira ever achieved.
Gilead is betting up to $750 million on Kymera’s anti-CDK2 molecular glue for solid tumors, while Sanofi elected to move forward with another protein degrader from the biotech, designed to target immune-mediated diseases.
The FDA is assessing the need for “further regulatory action” on Sarepta’s Duchenne muscular dystrophy gene therapy in the aftermath of two patient deaths, though the regulator has not yet specified what action this could be.
Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical officer for Usona Institute, a research organization advancing psychedelic science.
Despite Nektar’s share price shooting up as much as 175% on Tuesday, William Blair maintained that “there is an absence of clear differentiation” for rezpegaldesleukin in the atopic dermatitis space.