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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The antibody-drug conjugate beat the standard of care in second-line multiple myeloma, the company reported on Thursday, as it seeks to get the cancer drug back on the U.S. market.
The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies.
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The Anglo-Swedish drugmaker is making the investment to bolster its vaccine manufacturing and research and development capabilities in the U.K.
President Joe Biden has proposed expansions to the Inflation Reduction Act, including an increase in the annual number of prescription drugs that would be subject to price negotiations to 50, up from 20.
The early-stage oncology startup filed for an initial public offering on Wednesday, seeking funds to help develop its novel cancer therapies targeting extrachromosomal DNA.
The recently launched company shared two posters at the Muscular Dystrophy Association’s annual conference this week ahead of a March 21 PDUFA date.