Related coverage linked through entity extraction aliases.
Feb 25, 2026
Moderna partners with Recordati on propionic acidemia therapy for up to $160 million, while FDA Commissioner defends mRNA vaccine support following funding cuts and regulatory challenges.
Feb 25, 2026
Cytokinetics launches MYQORZO for obstructive hypertrophic cardiomyopathy following FDA approval, while C4 Therapeutics doses first patient in Phase 2 trial of cemsidomide for relapsed/refractory multiple myeloma.
Feb 25, 2026
The FDA approved pitolisant (Wakix) for treating cataplexy in children ages 6 and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Feb 25, 2026
Medtronic's diabetes unit MiniMed is seeking up to $7.86 billion valuation in its U.S. IPO while cutting 81 jobs at its Northridge facility ahead of the planned separation into a standalone publicly traded company.
Feb 24, 2026
A first-in-human trial shows individualized neoantigen mRNA vaccines generated multi-year T cell responses in early-stage TNBC patients, with 82.9% of targeted mutations eliciting measurable immune activation not detectable before vaccination.
Feb 24, 2026
Novo Nordisk plans to slash U.S. list prices for Wegovy and Ozempic by up to 50% starting January 2027, while securing European Commission approval for a new 7.2 mg dosage of Wegovy.
Feb 24, 2026
Enhertu combined with pertuzumab received FDA approval for first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in a decade. Real-world data show trastuzumab deruxtecan efficacy is consistent across patient subgroups.
Feb 24, 2026
Drug discovery outsourcing, preparative chromatography, and Latin America point-of-care diagnostics markets are forecast to grow at CAGRs between 7.5% and 8.2% through 2031, driven by biologics expansion and chronic disease prevalence.
Feb 24, 2026
Triple-agonist drug retatrutide has demonstrated weight loss outcomes similar to bariatric surgery in Phase 3 trials. Research shows GLP-1 drugs work through brain-mediated appetite suppression and are effective even in genetic obesity.
Feb 24, 2026
Replimune Group Inc. approaches a critical regulatory milestone as the FDA is scheduled to decide on its RP1 melanoma therapy by April 10, 2026, with cash reserves extending into early 2027.
Feb 24, 2026
MoonLake Immunotherapeutics says FDA feedback indicates sufficient data to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, while Relay Therapeutics received FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant breast cancer.
Feb 24, 2026
Novo Nordisk's next-generation obesity drug CagriSema achieved 23% weight reduction compared to 25.5% for Eli Lilly's tirzepatide in an 84-week trial, causing Novo shares to fall 15% and raising questions about its competitive position.
Feb 24, 2026
The FDA reversed its decision to reject Moderna's mRNA influenza vaccine application, accepting it for review one week after an initial refusal-to-file that reportedly involved senior leaders overruling staff advice.
Feb 24, 2026
The FDA issued draft guidance establishing a plausible mechanism framework for approving individualized therapies targeting ultra-rare diseases when randomized controlled trials are not feasible due to small patient populations.
Feb 24, 2026
The FDA released draft guidance establishing a new approval framework for individualized gene-editing and RNA-based therapies targeting ultra-rare diseases, allowing approvals based on small studies when traditional trials are not feasible.
Feb 24, 2026
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
Feb 24, 2026
The FDA has proposed new guidelines to create a pathway for approving bespoke therapies tested in small patient groups, specifically targeting rare genetic conditions and gene editing treatments that don't fit traditional approval systems.
Feb 24, 2026
Federal regulators unveiled a new regulatory approach to accelerate approval of personalized genetic treatments for rare, life-threatening conditions, allowing smaller studies when traditional large-scale trials aren't practical while maintaining post-market safety oversight.
Feb 23, 2026
Trader Joe's recalled chicken fried rice nationwide due to possible glass contamination after four customer reports. Separately, the FDA expanded a recall of McCain Foods tater tots to 648,000 pounds over plastic fragment concerns.
Feb 24, 2026
The FDA proposed a new framework to accelerate approvals of personalized treatments for rare genetic diseases, allowing drugmakers to rely on small studies when traditional trials are not feasible while requiring post-approval evidence collection.
