Feb 17, 2026
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
Feb 18, 2026
European regulators approved a 7.2mg "megadose" of Novo Nordisk's Wegovy involving three weekly injections. The Danish drugmaker filed suit against Hims & Hers after the telehealth company briefly launched a compounded oral semaglutide product.
Feb 17, 2026
The FDA has recalled over 20,000 single-serve peanut butter products made by Ventura Foods after blue plastic fragments were found in a production filter. The Class II recall affects 40 states and multiple private-label brands.
Feb 17, 2026
March of Dimes awarded the 2026 Richard B Johnston Jr, MD Prize to hematologist Leonard Zon for pioneering zebrafish research that illuminated blood development in embryos and led to breakthrough treatments for genetic blood disorders in children.
Feb 13, 2026
Scientists at Northwestern University developed human spinal cord organoids that accurately replicate injury responses including cell death, inflammation, and glial scarring. Testing showed a "dancing molecules" therapy significantly reduced scarring and promoted nerve regrowth.
Nov 28, 2025
The FDA approved tradipitant (Nereus), an oral NK-1 receptor antagonist, for prevention of motion-induced vomiting on December 30, 2025. The approval marks the first new pharmacologic treatment for motion sickness in over four decades.
Feb 19, 2026
Praxis Precision Medicines submitted NDAs for ulixacaltamide and relutrigine to the FDA, reported cash and investments of $926 million as of December 31, 2025, and disclosed a net loss of $303.3 million for full-year 2025.
Feb 19, 2026
The FDA has granted Fast Track designation to PLT012, a first-in-class anti-CD36 monoclonal antibody for hepatocellular carcinoma treatment. The Phase 1 trial is currently enrolling patients in Texas.
Feb 19, 2026
A single blood test measuring p-tau217 protein can predict when cognitively unimpaired individuals will develop Alzheimer's symptoms, with a margin of error of 3-4 years, potentially accelerating clinical trials.
Feb 19, 2026
The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.
Feb 19, 2026
The U.S. Food and Drug Administration issued two Emergency Use Authorizations on February 18, 2026, for NexGard products to treat New World screwworm infestations in dogs and cats.
Feb 19, 2026
Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.
Feb 19, 2026
The FDA has accepted for Priority Review Bristol Myers Squibb's New Drug Application for iberdomide in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target decision date of August 17, 2026.
Feb 19, 2026
The global oncology market is projected to grow from $280 billion in 2026 to $748 billion by 2035 at 11.54% CAGR, driven by rising cancer incidence, precision medicine expansion, and strong immunotherapy pipelines across multiple tumor types.
Feb 18, 2026
Novartis announced positive topline results from its Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint across three prevalent subtypes with significantly higher complete response rates versus placebo at Week 121.
Feb 18, 2026
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.
Feb 18, 2026
Johnson & Johnson announced plans to invest over $1 billion in a next-generation cell therapy manufacturing facility in Montgomery County, Pennsylvania, creating 500 biomanufacturing jobs as part of its $55 billion U.S. expansion commitment through 2029.
Feb 18, 2026
Alphyn Biologics has dosed the first patients in a Phase 2 trial of Zabalafin Hydrogel for Molluscum Contagiosum, enrolling 54 patients ages 6 months and older in a placebo-controlled study targeting 75% lesion elimination.
Feb 18, 2026
ImmunityBio's stock jumped 41.9% following the European Commission's conditional marketing authorization for Anktiva combined with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer across 33 European countries.
Feb 18, 2026
The European Commission has authorized a new 7.2 mg once-weekly dose of Wegovy (semaglutide) for adults with obesity across all 27 EU member states, following positive opinion from the EMA's scientific committee in December 2025.