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The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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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.
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressed—and there’s more to come in 2026.
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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 $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo mRNA-encoded CAR T therapy forward.
The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene therapy leaders gather for the annual meeting in Phoenix with the field in a state of flux; Pfizer and Amgen will make drugs available at a discount as President Donald Trump’s tariffs still loom; and new regulatory documents show how Pfizer beat out the competition for Metsera.
Takeda wanted to create something new in the cell therapy world by combining the technology with T cell engagers. A series of acquisitions in 2021 started the process.
As the industry loses one of its key female leaders in GSK CEO Emma Walmsley, BioSpace profiles the women leading the industry’s smaller biopharmas.
Drug pricing criticism often fixates on a price at a single point in time but drug pricing is never static.
Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli Lilly, joining former colleague Rachael Anatol, who was ousted from the agency not long after Marks.
MapLight laid out the terms of its planned IPO in a regulatory filing on Monday, providing greater detail about what the funds will be used for.
Of the three highest bidders, Pfizer’s purchase proposal for Metsera was the lowest, regulatory documents reveal. The New York pharma, however, offered the smoothest transaction with the greatest likelihood of success.
Skye Bioscience’s nimacimab fell short of investor and company expectations, but showed encouraging weight-loss results when combined with Wegovy, according to analysts at William Blair.
Amgen will offer its lipid-lowering drug Repatha directly to patients for $239 per month, representing a nearly 60% reduction from the current wholesale acquisition cost of $527.70.