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  • Eli Lilly acquires another pain biotech, its 11th deal this year, as FDA eyes decision on once‑weekly PrEP pill
    Eli Lilly announced the purchase of an Austin, Texas‑based pain biotechnology company, marking the 11th acquisition the Indianapolis‑based firm has completed in 2026. The deal expands Lilly's portf…
    Endpoints · 2mo agoDealNeutral↗ source
  • Health groups accuse HHS of rushing reinstatement of CDC vaccine advisory panel
    A coalition of health organizations has publicly charged the U.S. Department of Health and Human Services with attempting to accelerate the return of the CDC's Advisory Committee on Immunization Pr…
    Endpoints · 2mo agoRegulatoryNegative↗ source
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fda recalls67
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Psychiatry & CNS862
Ophthalmology494
Pain473
Endocrinology & Metabolism466
Infectious Disease444
  • UCSF spinout Kopra Bio secures $9.1M to advance virus therapy for glioblastoma in China
    Kopra Bio, a biotechnology company spun out of the University of California, San Francisco, announced it has raised $9.1 million in financing. The capital will be used to move its experimental viru…
    Endpoints · 2mo agoDealPositive↗ source
  • Be Bio halts hemophilia B cell-editing therapy trial
    Be Bio announced that it has terminated its clinical study of a hemophilia B therapy that used gene-editing of a patient’s own cells. The termination was recorded in a federal clinical-trials regi…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • OpenLoop Health says it can launch a virtual GLP-1 prescribing service in 24 hours
    OpenLoop Health says it can set up a telehealth operation that can prescribe GLP-1 medicines within a day. The company provides the medical‑group infrastructure that powers multiple virtual care p…
    Endpoints · 2mo agoNeutral↗ source
  • Medicare rule could bring subcutaneous Keytruda and Opdivo under price negotiations
    A federal rule proposed for 2029 aims to close a loophole that currently shields medicines moving from intravenous to subcutaneous administration from Medicare price negotiations. The Centers for M…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • J&J's Talvey plus Darzalex Faspro cuts death risk by up to 53% in relapsed multiple myeloma
    Johnson & Johnson reported that a combination of its immunotherapy Talvey with Darzalex Faspro, with or without Pomalyst, significantly lowered the risk of death in patients with relapsed or refrac…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • CMS proposes rule to close Medicare negotiation loophole for biologics
    CMS announced a proposed policy change that would clarify how the Centers for Medicare & Medicaid Services groups products for price negotiations under the Inflation Reduction Act. The rule target…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA says it will maintain Makary’s focus on clinical trials, rare diseases and China despite leadership exits
    The Food and Drug Administration announced that, even after the recent resignations of Commissioner Marty Makary and the heads of its drug and biologics centers, it will keep pursuing the policy ag…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Takeda releases additional Phase 3 data to bolster its orexin program amid new competition
    Takeda announced new results from its two Phase 3 trials of an orexin‑targeting therapy. The data are intended to demonstrate the drug’s efficacy and safety, reinforcing Takeda’s claim of market‑l…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Elicio Therapeutics’ KRAS pancreatic cancer vaccine fails in Phase 2, stock drops sharply
    Elicio Therapeutics reported that its KRAS‑targeted vaccine for pancreatic cancer did not improve patient outcomes in a mid‑stage (Phase 2) trial. The study results were released in a company state…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Gan & Lee reports positive Phase 3 obesity trial results; J&J shares multiple myeloma data
    Gan & Lee Pharmaceuticals, a China‑based insulin specialist, announced topline results from its Phase 3 obesity trial, indicating a successful outcome. The company said the study met its primary e…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Neumora Therapeutics halts lead depression drug after two more Phase 3 failures, plans 35% staff cuts
    Neumora Therapeutics announced that its lead depression candidate will be discontinued after it did not meet primary endpoints in two additional Phase 3 trials. The company said the data were consi…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Lilly reports early positive results for new JAK2 inhibitor in hard-to-treat myelofibrosis
    Lilly has incorporated a JAK2‑targeting drug originally discovered by Ajax Therapeutics after its recent acquisition. The experimental pill is intended for patients with myelofibrosis, a difficult‑…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Celiac disease faces new therapeutic possibilities as companies target underlying inflammation
    Celiac disease affects roughly one in every hundred people worldwide, imposing a daily burden that goes far beyond dietary restrictions. Currently, patients have no approved medicines and must rel…
    BioPharma Dive · 2mo agoPositive↗ source
  • HMNC Brain Health raises $50M Series B to advance two depression drugs
    HMNC Brain Health announced it has closed a $50 million Series B financing round. The capital will be used to move two depression drug candidates into mid-stage clinical trials. The round was led…
    Endpoints · 2mo agoDealNeutral↗ source
  • Lilly showcases Jaypirca combination data in CLL at EHA26, debuting results from Ajax acquisition
    Eli Lilly highlighted new blood‑cancer data at the European Hematology Association meeting in Stockholm. The company presented early clinical results for its Jaypirca therapy combined with the stan…
    Endpoints · 2mo agoNeutral↗ source
  • Strategic steps for moving sterile injectables from lab to clinical trials
    The article, sponsored by Vetter, discusses how drug owners of sterile injectable candidates face a key question when a molecule is ready for first‑in‑human studies: how fast can a clinical batch b…
    BioPharma Dive · 2mo agoPositive↗ source
  • Six Biopharma Leaders Drive LGBTQ+ Inclusion Amid Rising Anti-LGBTQ Legislation
    Six executives are spearheading initiatives to improve LGBTQ+ inclusion across the biopharmaceutical sector. Their work focuses on creating supportive policies, training programs, and community out…
    Endpoints · 2mo agoNeutral↗ source
  • Biopharma launches nominations for 2025 pay report and highlights Parabilis record IPO
    Endpoints Weekly announced the start of nominations for its eighth annual Women in Biopharma report, aiming to feature 20 distinguished women across science, leadership, and entrepreneurship. The…
    Endpoints · 2mo agoDealNeutral↗ source
  • Merck's Welireg and Keytruda combo receives FDA approval for adjuvant kidney cancer therapy
    Merck announced that its combination of the oral VEGFR inhibitor Welireg and the immunotherapy Keytruda has been cleared by the U.S. Food and Drug Administration. The clearance applies to patients…
    Endpoints · 2mo agoApprovalPositive↗ source
  • GSK completes $10.6 billion acquisition of Nuvalent, the largest in its history
    GSK announced it has completed a $10.6 billion purchase of Nuvalent, marking the biggest deal the company has ever undertaken. The transaction was disclosed on Tuesday and values Nuvalent at $124…
    Endpoints · 2mo agoDealNeutral↗ source
  • Enliven Therapeutics raises $400M as Jazz's Zepzelca misses confirmatory trial
    Enliven Therapeutics, a biotech based in Burlingame, California, announced that it priced a public offering of its common stock that raised about $400 million. The capital raise follows the compan…
    Endpoints · 2mo agoDealNeutral↗ source
  • Novo's M&A head joins Forbion as Perrigo CEO steps down over conduct concerns
    Novo's senior M&A executive has left the company to take a role at Dutch investment firm Forbion. Forbion, which manages a portfolio of biotech companies, has been active in M&A and aims to increa…
    Endpoints · 2mo agoNeutral↗ source
  • Amgen seeks FDA review of Tavneos to determine continued market availability
    Amgen has formally asked the U.S. Food and Drug Administration to re-examine the data supporting its drug Tavneos (avacopan). Tavneos is indicated for a rare form of vasculitis and the request sig…
    Endpoints · 2mo agoRegulatoryNeutral↗ source