News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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 LATEST
The company declined to exercise the license option for Harpoon Therapeutics’ TriTAC HPN217 program for multiple myeloma, which targets B cell maturation antigen, or BCMA.
During Wednesday’s annual R&D Day, Moderna said it is culling four programs from its pipeline, including two molecules that had been discontinued last year by AstraZeneca.
The Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in favor of Alnylam’s patisiran on whether its benefits outweigh its risks for patients with cardiomyopathy induced by transthyretin amyloidosis.
The company plans to launch up to 15 new products and bring up to 50 new candidates to the clinic over the next five years as part of its growth plan, while scaling down COVID-19 manufacturing.
Following cases of hepatobiliary toxicity leading to liver decompensation, Eiger has decided to drop its Phase III LIMT-2 trial of peginterferon lambda in chronic hepatitis delta.
Continuing its clinical win streak, AbbVie’s Skyrizi showed signs of superiority against Johnson & Johnson’s Stelara in topline data from a head-to-head Phase III Crohn’s disease study.
Topline data for the company’s CRF1 antagonist crinecerfont showed a significant drop in daily glucocorticoid dose, while maintaining androgen control in adult patients with the genetic disorder.
The agency’s briefing document found Phase III results investigating patisiran’s effects versus placebo were “small, of questionable clinical meaningfulness, and may not be detectable by patients.”
Citing a challenging macro environment, 2seventy bio is launching a sweeping strategic reorganization that will see 40% of its staff laid off and CEO Nick Leschly stepping down.
As the Novartis generics and biosimilars division nears its spin-off, Sandoz has signed a commercialization agreement with Samsung Bioepis, gaining rights to the latter’s Stelara biosimilar.