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The Fourth Circuit’s ruling follows a Supreme Court verdict that also allowed the Trump administration to move forward with its mass layoffs at federal agencies.
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Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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KSQ Therapeutics, Inc. announced today it has entered into a worldwide license and collaboration agreement with Roche for the development and commercialization of KSQ-4279.
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Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for confirmatory trials for therapies seeking the shortened path to market.
China is adapting its Life Sciences policy to bolster innovation and data transparency. Big Pharma is taking note.
Months after posting weight loss of 7.5% at 36 days for patients taking MET-097i, Metsera releases mid-stage results of just over 11% average body weight reduction at 12 weeks, with no plateau and a promising safety profile.
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information regarding models’ development and maintenance.
Denali’s failure on Monday continues biopharma’s losing streak against amyotrophic lateral sclerosis. PTC Therapeutics and Amylyx have seen similarly disappointing results.
From ADCs and radiopharmaceuticals to cell and gene therapies, eager young startups are betting on advances in biopharma’s most competitive therapeutic spaces—and attracting dollars from Big Pharma.
The acquisition from Wuxi Biologics, the embattled CDMO named in the BIOSECURE Act, marks another expansion of Merck’s manufacturing operations in Ireland.
Eli Lilly and Company has invested more than $20 billion in its manufacturing capabilities since 2020 to help meet high demand for its medicines. Its recently announced Lilly Medicine Foundry—which will support research and development efforts—is just the latest example of the ability to research new ways of producing medicines, while also scaling up manufacturing of medicines for clinical trials.
In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza.
Seeking Alpha analyst Terry Chrisomalis regards Viking Therapeutics as the most attractive M&A candidate in 2025, bolstered by its strong obesity candidate VK2735 and largely de-risked MASH therapy VK2809.