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Priovant’s brepocitinib is the first pill approved for the rare autoimmune disease — in a trial, more patients improved and got off steroids than on placebo.
The oral immunology drug ritlecitinib hit its co-primary endpoints in the TRANQUILLO studies, setting up filings for nonsegmental vitiligo, a condition with no approved oral therapy.
A US compounding group is marketing an under-the-tongue, unapproved version of the weight-loss drug to private UK clinics — a practice Novo Nordisk says risks patient safety.
The orexin-boosting pill treats the underlying biology of narcolepsy type 1 — keeping patients awake and curbing cataplexy — and opens a lucrative new drug class.
Abbott’s Libre Duo continuously measures glucose and ketones from a single sensor — and can warn of rising ketones before diabetic ketoacidosis becomes an emergency.
The KRAS G12C inhibitor earned the designation for previously treated advanced pancreatic cancer, one of oncology’s hardest targets, based on early-phase trial data.
Replimune’s oncolytic virus, given with nivolumab, won accelerated approval for melanoma that has progressed on immunotherapy — after two prior rejections.
The nationwide recall covers one lot of Tyenne (tocilizumab-aazg) injection after glass particles were found in the vials, a risk of irritation or vein inflammation.
Iberdomide is the first approved CELMoD — a next-generation protein degrader — cleared in a three-drug combination for multiple myeloma as early as first relapse.
Nipocalimab wins FDA approval for warm autoimmune hemolytic anemia — a disease in which the immune system destroys the body’s own red blood cells — giving patients their first dedicated therapy.
Otsuka's centanafadine is the first ADHD medicine to block reuptake of all three key neurotransmitters — a new mechanism for adults and children 6 and up.
Reported delays in delivering Nexviazyme — an enzyme therapy for a rare, progressive disease — follow an FDA warning letter over a Sanofi manufacturing site.
C2N Diagnostics’ PrecivityAD2 measures amyloid and tau markers from a blood draw — part of a fast-moving shift away from expensive scans and spinal taps for Alzheimer’s diagnosis.
The agency’s digital health leader says clarity is on the way — both broad guidance on generative AI and more specialized guidance for higher-risk uses.
Freenome's SimpleScreen offers a needle-in-arm alternative to stool tests and colonoscopy — but its blind spot for precancerous growths means it's no replacement for a scope.
The agency paused testing of RGX-121 after spinal MRI abnormalities turned up in patients treated years ago — the second clinical hold on a Regenxbio program in 2026.
The radiodiagnostic lets PET scans visualize tau neurofibrillary tangles — a core hallmark of Alzheimer’s — complementing existing amyloid imaging in patients being evaluated for the disease.
The antibody cut new abnormal bone formation by up to 90% in a trial for fibrodysplasia ossificans progressiva — a devastating disorder in which soft tissue slowly turns to bone.
Vitestro’s Aletta autonomously finds a vein and draws blood in adults, with one trained phlebotomist supervising up to three machines — a possible answer to a worsening staffing shortage.
The European Commission approved teclistamab plus daratumumab for relapsed multiple myeloma after a trial cut the risk of progression or death by more than 80%.
Revolution Medicines’ Rasonque (daraxonrasib) is the first targeted therapy to hit RAS — the mutation driving over 90% of pancreatic cancers — extending median survival to 13.2 months versus 6.7 on chemo.
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.