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  • California hospital lawsuits reveal forced McKinsey ties and surprise ER chain profits
    Unredacted comments from recent California hospital lawsuits show that hospital executives admitted to a "forced" partnership with consulting firm McKinsey, raising questions about the influence of…
    STAT · 1mo agoRegulatoryNegative↗ 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
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  • FDA accepts resubmission of Replimune’s RP1 cancer therapy, decision due Aug. 2; Merck KGaA announces $11 B life-sciences spend
    The U.S. Food and Drug Administration has accepted Replimune's resubmitted application for its cancer drug RP1, with a final decision slated for August 2 and an advisory committee meeting planned f…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • US biotech faces regulatory push as China licensing deals spark security concerns
    A surge in licensing agreements between Chinese pharmaceutical firms and U.S. biotech companies has been noted, with nearly 100 deals announced since early 2025, prompting worry among investors and…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • Alkermes CEO targets orexin market after strong narcolepsy pill data
    Alkermes' incoming chief executive outlined a strategy to compete with larger rivals in the emerging orexin drug class. Recent mid-June trial results showed the experimental oral compound alixorex…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • FDA proposes rule to require foreign tobacco makers to register and list products, aiming to curb illegal imports and protect youth
    The U.S. Food and Drug Administration announced on June 26, 2026 a proposed rule intended to strengthen its ability to identify illegal foreign tobacco products, including youth‑appealing e‑cigaret…
    fda press · 2mo agoRegulatoryPositive↗ source
  • Precision strategies help de-risk rare disease therapy launches
    Commercializing a rare disease therapy presents a high‑risk, high‑reward scenario for biotech firms. Small patient populations, stringent regulatory requirements, and the need to sustain value beyo…
    Fierce Biotech · 2mo agoNeutral↗ source
  • STAT readers split on spelling of "health care" as industry leans toward single word
    STAT recently asked its audience whether to write the term as two words or one. Roughly 60% of respondents favored one spelling over the other. The discussion highlights a subtle but growing trend…
    STAT · 2mo agoNeutral↗ source
  • STAT invites reader debate on blue zones and open-access publishing fees
    Torie Bosch, editor of STAT’s First Opinion platform, has published an opinion piece encouraging readers to submit letters responding to recent essays. The article explains that STAT will publish…
    STAT · 2mo agoNeutral↗ source
  • Daraxonrasib doubles median survival in pancreatic cancer trial, FDA grants early access
    An international study presented at the American Society of Clinical Oncology meeting in Chicago showed that patients with pancreatic cancer who received daraxonrasib lived an average of 13.2 month…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Tennessee pharmacies sell high-strength ivermectin under anti-vaccine doctor's direction
    Tennessee pharmacies have begun offering high-strength formulations of the antiparasitic drug ivermectin. The sales are being led by a physician known for anti-vaccine views, who has publicly said…
    STAT · 2mo agoNegative↗ source
  • Rural U.S. faces growing maternity care deserts despite falling fertility rates
    Pregnant women in many rural parts of the United States often must travel two hours or more to reach a hospital that can deliver a baby, putting them at risk if labor starts early or complications…
    STAT · 2mo agoNegative↗ source
  • Federal grant delays threaten disability research and services
    Grants from the National Institute on Disability, Independent Living, and Rehabilitation Research have been postponed by several months, leaving researchers uncertain about funding. The delays are…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Protego Biopharma appoints Jae Kim as chief medical officer
    Protego Biopharma announced the addition of Jae Kim to its executive team as chief medical officer. Kim comes to Protego after serving as chief medical officer at both Septerna and Design Therapeu…
    STAT · 2mo agoNeutral↗ source
  • FDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
    The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older. The 9-0 vote allows Moder…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • CMS recalculates 2026 Medicare Advantage star ratings, increasing program volatility and affecting $16 billion in bonuses
    Federal officials have issued a new memo that recalculates the quality ratings for 2026 Medicare Advantage plans. The change follows another lawsuit from insurers that contest lower star ratings,…
    STAT · 2mo agoRegulatoryNegative↗ source
  • FDA advisory panel backs Moderna seasonal mRNA flu vaccine after earlier controversy
    A Food and Drug Administration advisory committee unanimously endorsed Moderna’s seasonal mRNA flu vaccine on Thursday, after the product became the focus of controversy earlier this year when a se…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Eli Lilly stops 340B discounts for hospitals that did not submit required claims data
    Eli Lilly has begun withdrawing the federally mandated 340B price discounts from a handful of hospitals that have failed to provide the comprehensive claims data the company requires. The move fol…
    STAT · 2mo agoRegulatoryNegative↗ source
  • FDA lifts opposition to Huntington’s disease gene therapy, clearing path for development
    The Readout Loud podcast this week highlighted a regulatory shift for a gene therapy aimed at Huntington’s disease. The Food and Drug Administration reversed its earlier opposition, removing a key…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Eli Lilly stops 340B discounts for dozens of hospitals that did not submit claims data
    Eli Lilly has begun removing the federally mandated 340B price discounts for a few dozen hospitals that have not provided the required claims data. The company said the step follows a warning it is…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Ebola cases increase almost 40% in a week as death toll passes 200
    Ebola cases have increased almost 40% in a week in the current outbreak in Congo and Uganda as the death toll passes 200.
    STAT · 2mo ago↗ source
  • cAMPfield lands $180M to build gut disease drug
    The biotech is advancing an anti-inflammatory drug that originated with vTv for inflammatory bowel diseases, leaning on a better side effect profile.
    BioPharma Dive · 2mo ago↗ source
  • STAT+: Do wearables actually help people with cardiovascular disease?
    In this edition of STAT Health Tech: A look at what researchers found about if using wearables help people with cardiovascular diseases, and more.
    STAT · 2mo ago↗ source
  • STAT+: Cambrian’s experimental longevity drug mimics exercise
    What Soon-Shiong has delivered, Encanta's RSV antiviral, and other biotech news from The Readout
    STAT · 2mo ago↗ source
  • Biogen adds more immune drugs in $1B buyout of secretive startup RayThera
    The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues.
    BioPharma Dive · 2mo ago↗ source