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421 stories matching this filter · ← front page

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  • Pfizer CFO to step down; Denali sells a regulatory fast-pass
    A search is underway for a successor to Dave Denton, who took a job outside the pharmaceutical industry. Elsewhere, a new kind of Duchenne gene therapy got venture backing and a GSK deal paid divid…
    BioPharma Dive · 1mo ago↗ source
  • Kardigan extends biotech’s streak of big IPOs with $400M haul
    Including the heart drug developer’s offering, four biotechs in 2026 have raised at least $400 million in IPO proceeds — the most in a single year since 2021, according to BioPharma Dive data.
    BioPharma Dive · 1mo ago↗ source
  • FDA Approves First Single-Dose Generic Treatment for Influenza
    The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in…
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fda press21
fda recalls20
fda medwatch16
Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
fda press · 1mo ago
↗ source
  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
    The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
    BioPharma Dive · 1mo ago↗ source
  • Jazz zeroes in on next-gen T cell engagers with AbCellera deal
    The potentially $4 billion collaboration is the latest example of drugmakers working to broaden the use of T cell engagers, which, so far, have had limited success outside of certain blood cancers.
    BioPharma Dive · 1mo ago↗ source
  • A new Westlake-backed biotech takes aim at migraines
    Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention.
    BioPharma Dive · 1mo ago↗ source
  • Lilly buys non-opioid pain drugmaker 4E
    It’s the latest in a string of deals for Lilly, which has sunk more than $18 billion into acquisitions over the past few years.
    BioPharma Dive · 1mo ago↗ source
  • 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.
    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