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464 stories matching this filter · ← front page

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  • Express Scripts, PCMA sue to block Tennesee law breaking up PBMs and pharmacies
    Express Scripts and the PBM lobby are following in CVS Caremark’s footsteps in filing complaints challenging the FAIR Rx Act, which was passed earlier this year despite vehement opposition from PBMs.
    BioPharma Dive · 1mo ago↗ source
  • FDA staff scrutinizes evidence supporting Moderna’s flu vaccine
    Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year.
    BioPharma Dive · 1mo ago↗ source
  • Edgewise heart drug passes key trial test
    Still, the results leave somewhat unclear how different the company’s drug is than marketed hypertrophic cardiomyopathy medicines from Bristol Myers Squibb and Cytokinetics.
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BioPharma Dive · 1mo ago
↗ source
  • Neumora depression drug fails; EnGene to cut 50% of staff
    Neumora’s stumble is the latest setback for a once-promising class of brain drugs. Elsewhere, a cell therapy manufacturing specialist took steps toward an IPO and J&J made its latest U.S investment.
    BioPharma Dive · 1mo ago↗ source
  • FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
    The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergen…
    fda press · 1mo ago↗ source
  • FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
    On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…
    fda press · 1mo ago↗ source
  • Medicare drug price rule may target under-the-skin Keytruda and Opdivo
    For 2029, a federal rule proposes closing a "loophole" that protects medicines transitioning from intravenous administration from price protection.
    BioPharma Dive · 1mo ago↗ source
  • Lilly scores early positive data for new JAK drug
    Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.
    BioPharma Dive · 1mo ago↗ source
  • J&J multiple myeloma drug gains edge in earlier stage disease
    The latest results studying Talvey in combination with Darzalex Faspro support J&J’s efforts to expand the immunotherapy's use.
    BioPharma Dive · 1mo ago↗ source
  • Celiac disease is entering a new era of therapeutic innovation
    For the ~1 in 100 people living with celiac, the burden of disease extends far beyond their plate.
    BioPharma Dive · 1mo ago↗ source
  • Planning a successful pivot from lab to clinic
    For sterile injectables, key early decisions can have a significant impact on the products’ development.
    BioPharma Dive · 1mo ago↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 1mo ago↗ source
  • Rapport ‘fully prepared’ to launch seizure drug solo, CEO says
    In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
    BioPharma Dive · 1mo ago↗ source
  • Summit pulls $500M share sale a day after announcing it
    The developer of a leading PD-1/VEGF cancer drug cited “market conditions” for the cancellation. Its shares have struggled to break out following data milestones.
    BioPharma Dive · 1mo ago↗ source
  • Sensorion, citing Regeneron competition, shifts focus to a different hearing loss therapy
    A strategic review determined that the development environment had "notably changed," leading Sensorion to end work on its gene therapy for OTOF-related hearing loss.
    BioPharma Dive · 1mo ago↗ source
  • Novartis RNA drug acquired in $12B Avidity deal notches a trial win
    The data showed that del-brax, an “antisense oligonucleotide conjugate” being tested against a muscle-wasting disease, met its primary endpoint in a Phase 1/2 study.
    BioPharma Dive · 1mo ago↗ source
  • J&J looks to widen Imaavy’s use; $300M backs rare disease drug launch
    New data suggest Imaavy could be an effective treatment for autoimmune anemia. Elsewhere, Enliven detailed data for a Merck leukemia rival and MBX hyperparathyroidism drug hit its goal.
    BioPharma Dive · 1mo ago↗ source
  • FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
    FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and k…
    fda press · 1mo ago↗ source
  • Takeda’s $4B TYK2 drug tops Bristol Myers’ Sotyktu in head-to-head test
    The results support Takeda’s long-held belief in zasocitinib’s superiority and could help it gain a commercial advantage over Bristol’s therapy.
    BioPharma Dive · 1mo ago↗ source
  • Ethyreal starts up with $101M and takes aim at a pair of immune diseases
    The startup is developing a medicine that works differently than available treatments for thyroid eye disease and could benefit people with a related condition, too.
    BioPharma Dive · 1mo ago↗ source
  • Sanofi stops immune drug trial in latest research setback
    The failure adds to a series of mixed or negative readouts and leaves in doubt the future of a therapy Sanofi has viewed as a potential blockbuster.
    BioPharma Dive · 1mo ago↗ source
  • Parabilis sets a record with a $670M biotech IPO
    The largest-ever new stock sale for a venture-backed biotech company extends a streak of large IPOs in 2026 that’s now resulted in 12 drug startups securing more than $4.1 billion combined.
    BioPharma Dive · 1mo ago↗ source
  • AstraZeneca’s ‘extensive’ obesity drug push; $125M for ultrasound-aided genetic medicine
    Newly published data convinced AstraZeneca to conduct a sprawling late-stage program for its GLP-1 pill. Elsewhere, Bausch + Lomb will lay off 119 employees and Cartesian boosted its ‘in vivo’ cell…
    BioPharma Dive · 1mo ago↗ source
  • Merck, Gilead report mixed outcomes in key lung cancer, HIV studies
    Trodelvy's latest setback carries implications for a newly important Merck drug, while the success of a once-weekly HIV tablet could boost Gilead's main business.
    BioPharma Dive · 1mo ago↗ source
  • Stealthy startup Treeline plans a reverse merger
    Led by former Loxo Oncology CEO Josh Bilenker, the startup now has a trio of cancer drugs in early-stage testing and more following closely behind.
    BioPharma Dive · 1mo ago↗ source