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The White House has denied reports that the government could soon ban COVID-19 vaccines, noting that in the absence of an official announcement, “any discussion about HHS policy should be dismissed as baseless speculation.”
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Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.
As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out.
Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president.
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AIM ImmunoTech Inc. today announced the first subject has been dosed at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC Study”).
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Read our takes on the biggest stories happening in the industry.
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump administration could move forward with its sweeping reorganization of the agency.
HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval.
According to Makary, reducing user fees—which make up just under half of the FDA’s budget—could make it easier for smaller companies, individual investors and academics to participate in the process.
The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application in China and global clinical trials.
More than thirty years since its 1993 founding, Catherine Owen Adams and Elizabeth Thompson—the R&D combo that has led Acadia since last year—are managing two products on the market and a pipeline estimated to be worth an additional $12 billion in sales.
Despite the FDA commissioner’s promises of partnership and collaboration, personnel changes and continued federal cuts create uncertainty for an industry already struggling with nearly half a decade of investment scarcity.
The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its cardiovascular and kidney disease pipelines.
Takeda’s oveporexton improved wakefulness, attention and other key narcolepsy endpoints “with a high degree of statistical significance,” according to Jefferies analysts.
The development saga for the depression molecule has been rocky for years, unable to ease symptoms in multiple late-stage trials.
The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech noting that the regulator found its neurodevelopmental findings for the gene therapy to be “robust.”