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493 stories matching this filter · ← front page

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  • Researchers claim creation of first fully synthetic cell, launch public benefit corporation to share technology
    Researchers at the University of Minnesota reported in a preprint that they have built what they call a synthetic cell, dubbed "SpudCell," which they suggest may be the first of its kind. The team…
    STAT · 2mo agoPositive↗ source
  • STAT+: More signs that GLP-1s may help with peripheral artery disease
    Anthropic will begin developing drugs, BridgeBio pockets a billion, and more biotech news from The Readout
    STAT · 2mo agoRegulatoryNeutral↗ source
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  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 2mo agoApprovalPositive↗ source
  • Ipsen to buy Kartos Therapeutics for $450M, gaining Phase 3 myelofibrosis drug navtemadlin
    French pharmaceutical company Ipsen announced it will acquire California-based Kartos Therapeutics, paying $450 million upfront. The acquisition gives Ipsen control of navtemadlin, an MDM2 inhibito…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • FDA digital chief signals upcoming AI regulatory guidance
    STAT+ health-tech newsletter reported that the FDA’s digital leader offered a preview of forthcoming guidance on artificial intelligence. The briefing, delivered by Rick Abramson, highlighted the a…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 2mo agoNeutral↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 2mo agoRegulatoryPositive↗ source
  • 26 states file lawsuit to halt federal Medicaid work-requirement rule
    Five New England states joined 21 others in a lawsuit filed Monday to stop a federal rule that would add work requirements to Medicaid. The states argue the new guidelines create an unfair bureaucr…
    STAT · 2mo agoRegulatoryNegative↗ source
  • FDA adds peptide-focused physicians to advisory panel, raising conflict-of-interest concerns
    The FDA announced eight new members for a committee that will advise on whether compounding pharmacies can produce certain peptides. Most of the appointees are physicians or pharmacists who run bu…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Ipsen to acquire blood-cancer specialist Kartos Therapeutics for $450 million upfront
    Ipsen announced it will purchase Kartos Therapeutics, a company focused on blood cancers. The transaction includes a $450 million cash payment at closing, with the possibility of up to $1.75 billi…
    Endpoints · 2mo agoDealPositive↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • European regulators give second chance approval to Acadia’s Daybu for Rett syndrome
    European Medicines Agency's CHMP has reversed its earlier negative vote and now recommends marketing authorization for Acadia Pharmaceuticals' drug Daybu (trofinetide) for Rett syndrome. The posit…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • New poll shows only half of U.S. adults can afford quality health care, with record-high concerns for next year
    A recent West Health-Gallup Affordability Index found that roughly 50% of American adults said they could pay for health care and still access quality services in the past year. The survey also re…
    STAT · 2mo agoNegative↗ source
  • Cardiovascular biotech Kardigan raises $400M in IPO, fourth 2026 $400M+ offering
    Kardigan, a cardiovascular drug startup, priced a $400 million initial public offering on Wednesday, adding to a recent surge in large biotech offerings. The company becomes the fourth biotech in…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • STAT Health Tech examines whether wearables benefit cardiovascular patients
    Mario Aguilar writes in a STAT Health Tech newsletter that the issue of wearables for people with cardiovascular disease is under review. The piece notes that researchers have been studying whether…
    STAT · 2mo agoNeutral↗ source
  • Jazz partners with AbCellera on $4 billion deal to develop next-generation T-cell engagers for solid tumors
    Jazz Pharmaceuticals disclosed a collaboration with AbCellera aimed at creating next-generation T-cell-engaging antibodies for solid tumors. Under the agreement Jazz will pay $56 million up front…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Westlake-backed Vedana Therapeutics raises $46M to develop anti-PACAP migraine prevention drugs
    Vedana Therapeutics, a new biotech formed out of stealth, announced it has secured $46 million in financing backed by Westlake. The capital will be used to advance its anti-PACAP antibody program a…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Edgewise Therapeutics' experimental heart drug meets Phase 2 endpoints in cardiomyopathy trial
    Edgewise Therapeutics reported that its oral candidate EDG-7500 achieved the predefined goals of a Phase 2 study in both obstructive and non‑obstructive hypertrophic cardiomyopathy. The trial demo…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Biotech Converts Failed Trial Data into AI Model
    A biotech startup recently faced a setback when a clinical trial did not achieve its primary goals. Rather than discarding the results, the company chose to analyze the data for new insights. The…
    STAT · 2mo agoPositive↗ source
  • US spends $360,000 storing contraceptives meant for African aid, with most supplies nearing expiration
    The U.S. government spent roughly $360,000 between January 2025 and March 2026 to keep millions of dollars worth of contraceptives in climate-controlled storage, according to a recent USAID Office…
    STAT · 2mo agoNeutral↗ source
  • Alzheimer specialist admits she missed early signs in her own father, urging earlier detection
    A neurologist at the University of California, San Diego writes about her personal experience when her father began showing subtle cognitive changes that were missed. She recounts small mistakes a…
    STAT · 2mo agoNegative↗ source
  • FDA grants accelerated approval for Tzield to delay insulin loss in children with newly diagnosed Stage 3 type 1 diabetes
    The U.S. Food and Drug Administration issued an accelerated approval on June 12, 2026 for Tzield (teplizumab) to slow the decline of insulin production in pediatric patients aged 8 to 17 who have r…
    fda press · 2mo agoApprovalPositive↗ 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
  • 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
  • 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