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2,078 stories matching this filter · ← front page

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  • AbCellera reports striking Phase 2 results for hot-flash treatment, shares jump 31%
    AbCellera Biologics announced positive Phase 2 data for its neurokinin-3 receptor antagonist aimed at relieving vasomotor symptoms such as hot flashes. The company described the results as strikin…
    Endpoints · 2h agoPositive readoutPositive↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 5h agoNegative readoutNegative↗ source
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fda recalls35
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643
Vaccines594
Endocrinology & Metabolism318
Ophthalmology313
Pain306
Infectious Disease299
  • Sionna Therapeutics reports early-stage cystic fibrosis trial failure, dampening challenge to Vertex
    Sionna Therapeutics said its lead cystic fibrosis drug did not meet primary endpoints in an early-stage study, marking a setback for the company. The result reduces expectations that Sionna could…
    Endpoints · 2h agoNegative readoutNegative↗ source
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 2h agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 6h agoNegative readoutNegative↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 6h agoPositive readoutPositive↗ source
  • Silence Therapeutics’ divesiran shows 88% response in Phase 2 polycythemia vera trial, challenging Takeda’s upcoming drug
    Silence Therapeutics reported results from a Phase 2 study of its RNA-based therapy divesiran in patients with polycythemia vera, a rare blood cancer that causes excessive red blood cell production…
    STAT · 6h agoPositive readoutPositive↗ source
  • Safety concerns emerge as radiopharmaceuticals advance in cancer trials
    Radiopharmaceuticals are being hailed for their ability to deliver radiation directly to tumours, potentially sparing surrounding healthy tissue and improving cancer therapy. However, as more cand…
    STAT · 9h agoNegative↗ source
  • Global Ebola preparedness fixated on one strain, leaving gaps for other species
    Krutika Kuppalli, a former WHO medical officer, and virologist Placide Mbala write that the world’s readiness for Ebola has been narrowly focused. They draw on Kuppalli’s experience in the 2014‑201…
    STAT · 9h agoNegative↗ source
  • China clamps down on investigator-initiated clinical trials, tightening oversight
    China has announced tighter oversight of investigator-initiated trials (ITTs), requiring these studies to obtain approval from the National Medical Products Administration before they can begin. Th…
    STAT · 9h agoRegulatoryNeutral↗ source
  • RevMed partners with BeOne for Asian rights to RAS drugs as MoonLake reports Phase 3 success
    RevMed and BeOne have entered a partnership granting BeOne rights to commercialize RevMed’s RAS pathway drugs in selected Asian markets. The agreement also includes collaboration on upcoming clini…
    Endpoints · 2h agoDealPositive↗ source
  • FDA to require companies to notify agency of new food additives, creating public database
    The Health and Human Services Department announced a new policy that obligates manufacturers to inform the FDA when they introduce a new substance into human or animal food, and to explain how they…
    STAT · 2h agoRegulatoryNeutral↗ source
  • BioNTech veteran secures $25M seed round for virtual cancer surveillance startup
    A new virtual cancer surveillance company has closed a $25 million seed round, with the funding led by investors attracted to its novel approach to monitoring tumors. The company is headed by Ryan…
    Endpoints · 6h agoDealPositive↗ source
  • Scholar Rock removes Indiana manufacturing site from SMA drug application after FDA cites deficiencies
    Scholar Rock, a Massachusetts biotech, announced it is withdrawing an Indiana manufacturing facility from its filing for a prospective spinal muscular atrophy (SMA) therapy. The decision follows a…
    Endpoints · 34m agoRegulatoryNegative↗ source
  • States urged to use low-cost, scalable outreach for Medicaid enrollees facing 2027 eligibility changes
    States must begin notifying Medicaid beneficiaries about upcoming eligibility changes by September, as required by the One Big Beautiful Bill Act of 2025. The changes, set to take effect in 2027, i…
    STAT · 9h agoNeutral↗ source
  • STAT+: Ban prior auth? And hospitals cut jobs
    We examine a call to reform how health insurers do business, and a look at the impact of 340B restrictions.
    STAT · 2h ago↗ source
  • STAT+: FDA panel to weigh Grail’s Galleri test
    China reins in its biotech innovation engine, radiopharma boom meets unexpected hurdles, and more news from The Readout
    STAT · 2h ago↗ source
  • Aspo Oyj - Johdon liiketoimet
    Aspo Oyj Johtohenkilöiden liiketoimet 10.8.2026 klo 17.30
    globenewswire health · 3h ago↗ source
  • Aspo Plc - Managers' Transactions
    Aspo Plc Managers’ transactions August 10, 2026 at 17.30 EET
    globenewswire health · 3h ago↗ source
  • Jazz bets on epilepsy again by acquiring Actio for $820M upfront
    Jazz Pharmaceuticals will buy Actio Biosciences for $820 million upfront and up to $500 million more if certain milestones are met for its ultra-rare epilepsy drug. The deal further solidifies Jazz…
    Endpoints · 3h ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Sanofi drug shortage, a Jazz Pharma deal, and more
    Sanofi is experiencing shortages of two medicines used to treat Pompe disease after the FDA warned the company over manufacturing issues
    STAT · 4h ago↗ source
  • ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualms
    The FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.
    Fierce Biotech · 6h ago↗ source
  • Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug
    Scholar Rock has dropped Novo Nordisk’s troubled Catalent facility as a contract manufacturer in its FDA refiling for apitegromab, a spinal muscular atrophy candidate, after a recent inspection of…
    Fierce Biotech · 7h ago↗ source
  • MoonLake’s nanobody boosts all clinical endpoints in phase 3 psoriatic arthritis trial
    MoonLake Immunotherapeutics announced positive phase 3 data of patients with psoriatic arthritis treated with its lead nanobody candidate, sonelokimab.
    Fierce Biotech · 7h ago↗ source
  • Jazz pays $820M to buy Actio, adding clinical-stage asset to orchestra of epilepsy therapies
    Jazz Pharmaceuticals is adding to its orchestra of epilepsy treatments with the acquisition of Actio Biosciences for $820 million upfront.
    Fierce Biotech · 7h ago↗ source