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Moderna's mFLUSIVA approval offers a regulatory case study for mRNA vaccine sponsors, covering comparator selection lessons from the FDA's reversed refusal-to-file, competitive implications for Pfizer and Sanofi's mRNA flu programs, and what the accelerated approval pathway means for long-term regulatory risk.

BI-1808 plus pembrolizumab posted a 24% response rate in platinum-resistant ovarian cancer, tripling pembrolizumab's historical rate alone.

Neurocrine Biosciences has dosed the first participants in a Phase 1 study of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist for obesity, marking the company's entry into the increasingly competitive multi-agonist incretin therapeutics space.

Melanoma patients who failed anti-PD-1 therapy gain a new option after Replimune's oncolytic virus clears FDA on its third try.

The European Commission has approved an expanded indication for Bavarian Nordic's IMVANEX (MVA-BN) mpox and smallpox vaccine, extending eligibility down to children 2 to less than 12 years old, based on phase 2 data showing an immune response and safety profile comparable to adults.

Moderna expands the reach of mRNA technology with the first FDA-approved mRNA influenza vaccine, Merck seeks to extend RSV protection for vulnerable children, and AstraZeneca and CSPC deepen their manufacturing footprint in China.

Biotech companies entering new markets must consider talent availability, reimbursement strategy, and regional expertise early in development, according to Kirsten Detrick, chief representative, USA, at the Basel Area Life Sciences Supercluster.

Laurent Levy, founder and CEO of Nanobiotix, explains how a physics-based approach to drug delivery could complement existing therapeutic platforms by improving particle behavior in the body while avoiding added complexity.

Dr Steve Harr of Sana Biotechnology describes how converging islet transplant science makes a single-treatment cure for type 1 diabetes without immunosuppression an inevitable outcome.

Mediar Therapeutics has signed a collaboration and option agreement with Ono Pharmaceutical to co-develop novel antibody therapeutics targeting myofibroblast biology in fibro-inflammatory diseases, building on Mediar's existing three-program antifibrotic antibody pipeline.

Backed by an 84.3% drop in RSV hospitalizations, Enflonsia could extend protection to high-risk infants still vulnerable in their second season.

Sanofi has suspended a phase 2 trial of SAR445399, an anti-IL-1R3 monoclonal antibody, in non-cystic fibrosis bronchiectasis, part of new ceo Belén Garijo's ongoing portfolio review rather than a safety concern.

The FDA's approval of mFLUSIVA (mRNA-1010) extends Moderna's lipid nanoparticle platform to a new indication, with broad implications for biopharmaceutical manufacturing flexibility and regulatory precedent.