The personalized vaccine plus Keytruda cut the risk of melanoma returning after surgery — the first positive Phase 3 result for an mRNA-based, individualized cancer vaccine.
PIKTOR, an oral combination that hits the PI3K/AKT/mTOR pathway, won fast-track status alongside chemotherapy for endometrial cancer that has progressed despite prior treatment.
An observational analysis of more than 31,000 patients tied one widely used class of blood-pressure pills to a 33% higher risk of serious kidney events — though researchers stress it cannot prove cause.
In the Phase 3 SAFFRON trial, adding Hutchmed’s Orpathys to Tagrisso delayed progression and extended overall survival in EGFR-mutated lung cancer that had developed a MET-driven resistance.
While the industry chases GLP-1 agonists for weight loss, Amylyx went the other way — and its GLP-1 antagonist cut severe hypoglycemic events by 55% in a late-stage trial.
After shelving its sickle cell program over safety concerns, Fulcrum is combining with Slate Medicines in a reverse merger built around a next-generation migraine drug.
Researchers paired live malaria parasites with a drug that stops them in the liver, converting infectious bites into immunizing events that produced durable protection in animals.
The company’s long-acting retina treatment failed to prove non-inferiority to standard therapy across the full trial, wiping out nearly $1 billion in market value.
The antibody drug improved muscle strength and function in adults with inflammatory muscle disease, setting up a potential label expansion for a therapy already generating billions.
By fusing therapeutic antibodies to albumin, researchers cut how much of the drug crosses the placenta — without sacrificing the long-lasting effect that makes these medicines useful.
The world’s largest biosimilar maker will commercialize up to 10 Henlius-developed copies of blockbuster biologics globally, positioning for one of the industry’s biggest-ever patent cliffs.
European regulators have validated the marketing application for a six-valent Lyme vaccine that showed more than 70% efficacy in a 9,437-person Phase 3 trial. No human Lyme vaccine is currently approved.