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The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating erythropoietic protoporphyria.
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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.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
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.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Acelyrin earlier this month agreed to an all-stock merger with fellow immune player Alumis, with their combined cash tiding the combined company over until 2027.
The move comes weeks after Pfizer terminated its partnership with Sangamo Therapeutics for another hemophilia gene therapy.
Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers.
The postponed ACIP meeting comes barely a week after Robert F. Kennedy, Jr. was confirmed as Secretary of Health and Human Services, despite controversy regarding his anti-vaccine history.
The meeting, which will include Pfizer CEO Albert Bourla as the newly named board of directors’ chair, will reportedly cover key topics for the lobbying group, including the Inflation Reduction Act.
BridgeBio beat investor expectations with 1,028 unique prescriptions for ATTR-CM therapy Attruby, setting the company up to beat a 2025 sales consensus of $86 million.
Morale is low at the FDA, which was hit with layoffs this week following RFK Jr.’s confirmation. Biopharma leaders and agency insiders fear further workforce cuts could delay new medicines.
A year ago, AstraZeneca walked away from the bulk of its roxadustat partnership with FibroGen—though the pharma at the time decided to retain its relationship with the biotech’s China operations.
Despite the regulatory setback, analysts appear optimistic, noting that Harmony’s long-term prospects remain bright given the development of its high-dose formulation of its sleep-regulating drug Wakix.
Despite expectations of dealmaking leniency, new FTC chairman Andrew Ferguson told staff that he will retain the current 2023 FTC and DOJ guidelines on mergers, upholding stricter anti-trust scrutiny on deals.