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323 stories matching this filter · ← front page

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  • Neurocrine’s rare-disease drug approved but later linked to deaths and serious side effects
    Neurocrine Biosciences received regulatory approval for a rare‑disease therapy after a small clinical trial showed modest efficacy and side effects that were considered manageable. The decision was…
    STAT · 23h agoRegulatoryNegative↗ source
  • European regulators withdraw Amgen's Tavneos over questionable data
    European regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading. The authorities said the data s…
    Endpoints · 15h agoRegulatoryNegative↗ source
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  • Eli Lilly moves to curb black-market sales of retatrutide amid rising illicit demand
    Eli Lilly announced steps to address the growing black‑market trade of its obesity/diabetes drug retatrutide, which has seen increasing illicit use. The company is working with law‑enforcement and…
    STAT · 19h agoRegulatoryNegative↗ source
  • Commure ends referral payment program for its AI clinic tools
    Commure, a health-software firm valued at about $7 billion, announced it is ending the referral-payment arrangements it had with partners who promoted its artificial-intelligence products to medica…
    STAT · 12h agoNeutral↗ source
  • Neurocrine's Prader-Willi drug Vykat XR linked to multiple deaths and serious side effects
    A group of physicians and experts in Prader-Willi syndrome warned clinicians about safety concerns with Vykat XR, a drug approved by the FDA in March 2025 to reduce the intense hunger in patients w…
    STAT · 2d agoRegulatoryNegative↗ source
  • Definium's LSD pill shows significant anxiety reduction in Phase 3 trial
    Definium Therapeutics announced results of a Phase 3 trial testing its LSD‑based pill DT120 in patients with generalized anxiety disorder. The study enrolled 214 participants who received a single…
    STAT · 1d agoPositive readoutPositive↗ source
  • Lilly sues over black-market retatrutide; Neurocrine's new obesity drug linked to patient deaths
    Eli Lilly has filed six lawsuits against U.S. companies it says are illegally selling black-market versions of its experimental obesity drug retatrutide. The company alleges the defendants are dist…
    STAT · 1d agoRegulatoryNegative↗ source
  • Commure's AI-driven referral program draws complaints of financial losses from health-care customers
    Commure, a Silicon Valley startup valued at $7 billion, builds AI tools aimed at automating health‑care administrative work such as scheduling, billing and prior‑authorization. According to intern…
    STAT · 2d agoNegative↗ source
  • Postpartum psychiatry remains inadequately understood, case of Lindsay Clancy highlights gaps
    The opinion piece, authored by a neuroscience professor at Tufts, an obstetrics‑psychiatry specialist at NewYork‑Presbyterian and Weill Cornell, and a psychiatry researcher at the University of Vir…
    STAT · 1d agoNegative↗ source
  • Renowned autoimmune researcher Georg Schett co-founds biotech to develop antibody therapies
    Georg Schett, a German scientist noted for pioneering CAR‑T approaches in autoimmune disease, is now launching a new biotech venture. The startup, which has not yet been named in the report, will…
    STAT · 1d agoDealPositive↗ source
  • Medicaid to End Funding for Gender-Affirming Surgeries and Hormone Therapy for Transgender Youth
    The Trump administration announced that Medicaid will no longer cover gender-affirming surgeries and hormone treatments for minors. The change also applies to the Children’s Health Insurance Progr…
    STAT · 2d agoRegulatoryNegative↗ source
  • Epicrispr secures $90M Series C to advance epigenetic therapy for rare muscle disease
    Epicrispr Biotechnologies announced a $90 million Series C financing round, led by Octagon Capital and Janus Henderson Investors, with participation from Sanofi Ventures and other investors. The c…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Hemab Therapeutics IPO raises $301.5M, stock triples and funds runway to 2029
    Hemab Therapeutics completed an upsized $301.5 million IPO in May, boosting total proceeds to $346.7 million. The offering helped the company’s share price climb from $18 at debut to $53.48 by mid‑…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Deerfield-backed Boulevard Bio raises $65 million and unveils three autoimmune drug candidates
    Boulevard Bio, a New York‑based biotech focused on B‑cell biology, announced it has emerged from stealth with $65 million in financing from Deerfield Management. The funding supports the developmen…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Epicrispr raises $90 million Series C after promising early data on epigenetic FSHD therapy
    Epicrispr Biotechnologies announced a $90 million Series C financing round to advance its research program. The company shared early data suggesting that an epigenetic approach could address facio…
    Endpoints · 2d agoDealPositive↗ source
  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 2d agoDealPositive↗ source
  • Zydus Sentynl signs up to $475M deal to license Mereo's phase-3 ready rare lung disease drug alvelestat in U.S.
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, announced a licensing agreement with Mereo BioPharma for the U.S. rights to alvelestat, a neutrophil elastase inhibitor that has completed…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Skylark Bio launches first-in-human gene therapy trial targeting deafness
    Skylark Bio, which has operated in stealth, announced that it has dosed the first patient in a gene-therapy trial aimed at treating hearing loss. The study marks the company's entry into the emergi…
    STAT · 2d agoPositive↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 3d agoRegulatoryNeutral↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences for $820 million upfront, targeting ultra-rare epilepsy
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, a company developing an ultra‑rare epilepsy therapy. The transaction includes an upfront cash payment of $820 million, with the p…
    Endpoints · 3d agoDealPositive↗ 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 · 3d agoNegative readoutNegative↗ source
  • Jazz Pharma to acquire Actio Biosciences for $820M, adding KCNT1+ epilepsy drug to its pipeline
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences for an upfront payment of $820 million, expanding its portfolio of epilepsy medicines. The deal brings Actio’s lead candidate, ABS…
    Fierce Biotech · 4d agoDealPositive↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 4d agoPositive readoutPositive↗ 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 · 3d agoRegulatoryNegative↗ source
  • Vaderis raises $152 million Series B to launch Phase 3 trial for rare vascular disease
    Vaderis Therapeutics announced it has closed an oversubscribed $152 million Series B round to fund its AKT inhibitor program. The capital will support a newly launched Phase 3 study of the oral dr…
    Fierce Biotech · 3d agoDealPositive↗ source