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The accelerated approval lets patients with HER2-mutant non-small cell lung cancer take sevabertinib right away, without needing to try chemotherapy first.
Hospital pharmacists and industry are jointly pushing to extend medicine barcodes down to the individual dose — a change they say could sharply cut bedside medication errors.
Three lots of the hospital multi-dose vials are being pulled nationwide after reports of leaking, cracked containers and particulate contamination that could be life-threatening if injected.
With two suppliers shutting down, the FDA is deploying regulatory tools to prevent a shortage of the intravenous nutrition that premature and critically ill babies depend on.
Camizestrant is the first cancer therapy cleared based on spotting a resistance mutation in circulating tumor DNA — letting doctors switch treatment before scans show the cancer is growing again.
Ionis’s Zanvastro, an antisense drug that dials down a toxic protein, stabilized walking in patients with the ultra-rare, progressive neurological disorder — which until now had no disease-modifying therapy.
After a bruising regulatory saga, the company submitted AMT-130 — a one-time, brain-delivered gene therapy that slowed disease progression over three years — for accelerated approval.
The long-acting interferon, already used for a related blood cancer, beat an older drug at controlling platelet counts and cutting clot-related events in a Phase 3 trial.
Stryker’s SportSuite Vision overlays scans and arthroscopic images in a surgeon’s field of view — and just guided its first real operation, a hip arthroscopy at Duke.
The bictegravir/lenacapavir tablet gives virologically suppressed adults — including those on complex regimens — a new one-pill, once-a-day option.
Rusfertide mimics the body’s iron-regulating hormone to rein in red-blood-cell overproduction — and in a trial, most patients no longer needed regular blood draws.
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.
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.
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.
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 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.
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 European Commission approved teclistamab plus daratumumab for relapsed multiple myeloma after a trial cut the risk of progression or death by more than 80%.
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 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.
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.
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.
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.
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.
Reported delays in delivering Nexviazyme — an enzyme therapy for a rare, progressive disease — follow an FDA warning letter over a Sanofi manufacturing site.
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.
Replimune’s oncolytic virus, given with nivolumab, won accelerated approval for melanoma that has progressed on immunotherapy — after two prior rejections.
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.
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 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.
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.
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.