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While ersodetug missed the Phase 3 primary endpoint of a reduction in hypoglycemia events, Rezolute argued that this goal was confounded in part by behavioral factors. The FDA acknowledged the validity of this argument.
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If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit.
Eli Lilly and Regeneron are leading the push to treat congenital deafness with gene therapies, seeking a piece of a potential billion-dollar market and banking on local delivery and the small amount of drug required to overcome key safety concerns.
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
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While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
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The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
Last month, biopharmas let go or projected they would let go of less than 500 people combined, based on BioSpace estimates, down almost 1,000 from January 2025. Still, competition for open jobs remains strong, with employed and unemployed biotech and pharma professionals eyeing their next roles.
A recurring theme Tuesday morning at Phacilitate’s Advanced Therapies Week was the quickly emerging potential of in vivo approaches to cell and gene therapy—a trend also reflected in recent investments by Eli Lilly and Regeneron.
The Taiwan-based company is establishing a manufacturing center for the U.S. market.
The pact between Madrigal Pharmaceuticals and Ruzhou Ribo Life Sciences could complement the former’s Rezdiffra, the first FDA-approved therapy for MASH. That drug made $287.3 million in the third quarter of 2025.
With 10 launches planned in the coming quarters, Gilead isn’t feeling the same acquisition urgency as its pharma peers—though the prospect of a takeover isn’t off the table.
The percentage of patients achieving total clearance of eczema lesions in a Phase 2b trial increased with prolonged rezpeg treatment.
After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.
A lawsuit and FDA warning ensued after Hims & Hers launched a compounded version of Novo Nordisk’s new obesity pill, more Big Pharma report earnings—including from weight loss rivals Novo and Eli Lilly—and the gene therapy space sees another rejection.
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