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521 stories matching this filter · ← front page

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  • AbiVax shares plunge as safety concerns shadow strong ulcerative colitis trial results
    AbiVax reported Phase 3 data for its experimental therapy obefazimod in patients with moderately to severely active ulcerative colitis. Two dose levels achieved placebo‑adjusted clinical remission…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Radiopharmaceutical shows promise after Pluvicto; Vera Therapeutics gains FDA agreement to speed IgA nephropathy data analysis
    A new radiopharmaceutical is generating interest for use after patients have completed Pluvicto therapy, suggesting a potential follow‑on treatment option. Abivax reported encouraging results from…
    STAT · 3mo agoRegulatoryNeutral↗ source
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fda recalls67
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Pain478
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Infectious Disease444
  • Agios pays $25 million for global rights to Oscotec’s SYK inhibitor cevidoplenib
    Agios Therapeutics announced it has secured an exclusive worldwide license for Oscotec’s experimental SYK inhibitor, cevidoplenib. Under the agreement, Agios will pay $25 million up front to Oscot…
    Endpoints · 3mo agoDealNeutral↗ source
  • Orphan drug sales projected to exceed 21% of prescription market by 2032, driven by strong pipeline and policy support
    Orphan drug developers continue to see robust sales growth even as the broader pharmaceutical industry faces pricing and policy turbulence. The latest Evaluate Orphan Drugs Report highlights that s…
    BioPharma Dive · 3mo agoPositive↗ source
  • RallyBio pursues second reverse merger, this time with cancer drug developer Avenzo Therapeutics
    RallyBio announced on Monday that it will merge with cancer-focused Avenzo Therapeutics in a reverse‑merger transaction. The combined entity will operate under the Avenzo Therapeutics name. The de…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Hospitals grapple with patient requests for unvaccinated donor blood
    Some patients are now asking hospitals to provide blood that comes only from donors who have not received any COVID-19 vaccine, creating a new set of ethical and logistical questions. The demand r…
    STAT · 3mo agoNeutral↗ source
  • Ultra-low dose nivolumab shows survival benefit for head and neck cancer patients in India
    Researchers presented data at the American Society of Clinical Oncology meeting showing that an ultra‑low dose of the PD‑1 inhibitor nivolumab, given with chemotherapy, extended survival for patien…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Personalized vaccines show promise in extending survival for some brain cancer patients, Dana-Farber study finds
    Personalized cancer vaccines are being investigated as a way to make aggressive brain tumors more responsive to immunotherapy, according to new research from the Dana-Farber Cancer Institute. The…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Replimune to file third FDA application for RP1 cancer therapy after productive talks
    Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Admin…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Allogene CEO David Chang to step down as Agios drug misses mid-stage trial results
    Allogene announced that its chief executive, co‑founder David Chang, will leave the role after an eight‑year tenure. Chang, who previously worked at Kite Pharma, will remain on the company’s board…
    BioPharma Dive · 3mo agoNegative readoutNeutral↗ source
  • US says Ebola patients will be evacuated to Europe, not treated in America, as outbreak grows
    The World Health Organization is reviewing which vaccines could help curb the expanding Ebola outbreak in Africa. The U.S. government announced it will no longer bring Americans infected with Ebol…
    STAT · 3mo agoRegulatoryNegative↗ source
  • XPRIZE Healthspan launches $101 million competition to test anti-aging therapies in older adults
    Jamie Justice, former Wake Forest professor, now leads XPRIZE Healthspan, a global contest aimed at finding treatments that can restore muscle, cognition and immune function in older people. The c…
    STAT · 3mo agoPositive↗ source
  • GSK and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Experts debate testing Merck’s Ervebo vaccine for DRC Ebola outbreak amid lack of approved shot
    The Democratic Republic of the Congo confirmed a new Ebola outbreak at the end of May, making it the fourth largest on record. The virus is spreading in a conflict-affected region, complicating con…
    STAT · 3mo agoNegative↗ source
  • Podcast interview challenges the scientific basis of blue zones after 25 years of hype
    In a recent First Opinion podcast, Eric Topol and Shelley Wood discuss the rise of the blue zone concept over the past quarter century. They note that the idea began with isolated communities said…
    STAT · 3mo agoNeutral↗ source
  • Biotech execs push for Rick Pazdur as FDA chief while Takeda announces 4,500 layoffs
    Hundreds of biotechnology executives, investors and patient advocates have signed a petition urging President Trump to nominate Rick Pazdur as the next FDA commissioner. Pazdur, a longtime FDA vet…
    BioPharma Dive · 3mo agoLayoffsNeutral↗ source
  • AC Immune CEO Andrea Pfeifer Retires After 23 Years, Company Begins CEO Search
    AC Immune announced that its chief executive Andrea Pfeifer will step down after a 23‑year tenure. Pfeifer, who has guided the biotech through multiple development programs, said she will retire a…
    Endpoints · 3mo agoNeutral↗ source
  • BeOne secures FDA approval for lymphoma therapy
    BeOne received FDA approval for its lymphoma therapy, a notable achievement in a crowded therapeutic area. The agency’s review concluded that the treatment meets safety and efficacy standards, pla…
    STAT · 3mo agoApprovalPositive↗ source
  • Regenxbio reports key gene therapy results, moves toward FDA accelerated clearance for Duchenne
    Regenxbio said its experimental gene therapy RGX-202 met the primary endpoint in a pivotal Duchenne muscular dystrophy trial, positioning the company to file for accelerated FDA clearance. In the…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • AVB-001 Cell Therapy Demonstrates Safety and Immune Activation in Platinum-Resistant Ovarian Cancer
    AVB-001, an encapsulated interleukin-2 cell therapy, was evaluated in patients with platinum-resistant high-grade serous ovarian carcinoma. The study reported that the treatment was well tolerated.…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Triplet immunotherapy improves survival in HER2‑positive gastric cancer, suggesting broader immune activation
    New data from a study of HER2‑positive gastric cancer patients evaluated a triplet immunotherapy regimen. The analysis compared the combination against standard approaches and focused on overall su…
    onclive · 3mo agoPositive readoutPositive↗ source
  • CREATE Medicines raises $122 million to advance CAR-T candidates into human trials
    CREATE Medicines, formerly Myeloid Therapeutics, announced a $122 million financing round. The funding came from Newpath Partners, ARCH Venture Partners, Hatteras Venture Partners and other invest…
    STAT · 3mo agoDealPositive↗ source
  • FDA approves oral decitabine/cedazuridine plus venetoclax for older AML patients unable to tolerate intensive chemo
    The FDA has approved the oral combination of decitabine/cedazuridine (Inqovi) with venetoclax (Venclexta) for adults with newly diagnosed acute myeloid leukemia who are at least 75 years old or hav…
    onclive · 3mo agoApprovalPositive↗ source