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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.
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.
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
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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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In an interview with German-language outlet Neue Zuercher Zeitung, Novartis CEO Vas Narasimhan said the company is exploring ways to remove or minimize the drug price gap between the U.S. and its other markets in similarly developed countries.
For the last two years, Keytruda has reigned as the world’s top-selling drug—a distinction under threat with key patent protections expiring in 2028.
Building and scaling biopharma workforces can go beyond recruiting permanent employees to include fractional workers and consultants. A Slone Partners executive discusses how these blended workforces operate, highlighting the strategic benefits.
The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps the regulator could take to help patients.
With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval.
A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.”
After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role.
Bluebird bio has re-emerged after a private equity buyout as Genetix Biotherapeutics, marking a return to its roots and a new path forward for manufacturing.
BMO Capital Markets analysts said the first day of the CDC vaccine advisory committee meeting Thursday had anti-vaccine overtones as the panel, which was revamped by Health Secretary Robert F. Kennedy, Jr. in June, voted to recommend that children under four receive the measles, mumps, rubella (MMR) vaccine separately from a chickenpox vaccine. Today the advisors will vote on changing the childhood schedule for the hepatitis B and COVID-19 vaccines.
Investors had been “holding out hope” that there remained a regulatory path forward for RP1, but results of Replimune’s Type A meeting with the FDA do not appear to support this, according to BMO Capital Markets.