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  • Avalyn Pharma raises $300M in IPO to fund inhalable lung-fibrosis drugs
    Avalyn Pharma completed a $300 million initial public offering, pricing 16.7 million shares at $18 each and exceeding its original $200 million target. The proceeds will be used to develop inhalab…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Study finds OpenAI large language model outperforms doctors in diagnostic and clinical reasoning tasks
    Researchers from Boston published a paper in Science describing a series of experiments that tested an OpenAI large language model on real‑world diagnostic and clinical reasoning cases drawn from a…
    STAT · 4mo agoPositive readoutPositive↗ source
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  • New quintuple-agonist obesity drug shows strong weight loss results in mice
    A preclinical study reported that a novel "quintuple agonist" compound, designed to activate five metabolic pathways, produced marked weight loss in mice. The researchers said the drug outperformed…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Cigna to Leave ACA Individual Market in 2027, Shifting Focus to Core Business
    Cigna announced it will withdraw from the Affordable Care Act’s individual exchanges starting in 2027, a move revealed on its first‑quarter earnings call. The insurer currently covers about 369,00…
    STAT · 4mo agoRegulatoryNegative↗ source
  • AstraZeneca to Resume Expansion of Cambridge R&D Site After US-UK Trade Deal Boosts UK Drug Spending
    AstraZeneca announced it will restart the expansion of its research and development facility in Cambridge, United Kingdom. The move marks the first R&D project to be revived since the recent United…
    STAT · 4mo agoPositive↗ source
  • New OBSCORE tool predicts risk of 18 obesity-related complications to guide GLP-1 therapy
    A new predictive model called OBSCORE has been introduced to identify individuals at risk for a range of obesity‑related health problems. The tool expands on the traditional body‑mass index metric…
    STAT · 4mo agoPositive↗ source
  • Congress urged to hold RFK Jr. accountable after health policy hearings
    Former Republican congressmen and physicians Michael Burgess and Larry Bucshon wrote an opinion piece calling on lawmakers to keep pressure on Health and Human Services Secretary Robert F. Kennedy…
    STAT · 4mo agoNegative↗ source
  • FDA appoints Katherine Szarama as acting director of vaccines and biologics center
    The FDA announced that Katherine Szarama will serve as the acting director of the Center for Biologics Evaluation and Research (CBER), the agency's unit that oversees vaccines, gene therapies and t…
    STAT · 4mo agoNeutral↗ source
  • Trump nominates radiologist Nicole Saphier as third surgeon general candidate, emphasizes vaccine schedule questions
    The White House announced Dr. Nicole Saphier as its third nominee for surgeon general, replacing the previously considered candidate whose medical license had lapsed. Saphier is a board‑certified…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • STAT podcast highlights investor buzz around hair loss drugs, AI in trials, and Servier's M&A ambitions
    The latest episode of STAT’s “The Readout LOUD” podcast explored why investors are increasingly focused on treatments for hair loss, noting recent trial data that has generated notable market inter…
    STAT · 4mo agoNeutral↗ source
  • Akeso‑Summit’s ivonescimab lands a prime ASCO plenary slot despite unclear survival data
    The upcoming American Society of Clinical Oncology meeting will feature a plenary presentation from Akeso and Summit Therapeutics on their lung‑cancer candidate ivodescimab. Industry observers note…
    STAT · 4mo agoNeutral↗ source
  • HHS Appeals Court Ruling Blocking Health Secretary Kennedy’s Vaccine Policy Changes
    The Department of Health and Human Services has filed an appeal to a federal circuit court challenging a judge’s preliminary ruling that halted several of Health Secretary Robert F. Kennedy Jr.’s p…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Hinge receives FDA clearance for new migraine device
    Hinge announced that its migraine treatment device has received clearance from the U.S. Food and Drug Administration. The clearance allows the company to market the device in the United States and…
    STAT · 4mo agoApprovalPositive↗ source
  • Trump withdraws Casey Means as surgeon general nominee, names radiologist Nicole Saphier
    The Trump administration has withdrawn its nomination of Casey Means to serve as the next surgeon general. Means had been backed by the Make America Healthy Again movement, which sees the decision…
    STAT · 4mo agoNegative↗ source
  • New data link rising wildfire smoke to greater health risks, while FDA confirms infant formula safety
    Recent analyses show that smoke from increasingly frequent wildfires is contributing to higher levels of air pollution, which researchers say is linked to a range of adverse health outcomes. The U…
    STAT · 4mo agoNeutral↗ source
  • Data show international medical graduates are not displacing U.S. doctors in 2026 residency match
    The opinion piece examines a social‑media narrative that International Medical Graduates (IMGs) are taking residency slots away from U.S. medical graduates. The authors cite the 2026 Main Residenc…
    STAT · 4mo agoNeutral↗ source
  • Chiesi to acquire KalVista for $1.9 billion, adding oral hereditary angioedema drug Ekterly to its rare-disease portfolio
    Chiesi Group announced it will purchase KalVista Pharmaceuticals for $1.9 billion, gaining ownership of Ekterly, an oral on‑demand treatment for hereditary angioedema (HAE). Ekterly received FDA a…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • FDA pilots real-time clinical trials as Amgen, AstraZeneca join proof-of-concept studies; AbbVie eyes KRAS biotech Kestrel
    The U.S. Food and Drug Administration announced a pilot program for "real-time" clinical trials, designed to cut the lag between data collection and regulatory review. AstraZeneca and Amgen have l…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Chiesi to acquire KalVista for $1.9 billion, adding hereditary angioedema pill to rare-disease portfolio
    Italian pharmaceutical group Chiesi announced it will purchase KalVista Therapeutics for $1.9 billion. The transaction values KalVista at $27 per share, a 40 percent premium to its last closing pri…
    STAT · 4mo agoDealPositive↗ source
  • Supreme Court hints skinny labeling may remain viable for generic drugs
    At a hearing, Supreme Court justices heard arguments about skinny labeling, a practice used by generic manufacturers to seek approval for a subset of a brand drug's indications. The justices did n…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Health AI discourse shifts from hype to practical discussion, says STAT newsletter
    Brittany Trang, a health‑tech reporter at STAT, reflects on how the conversation around artificial intelligence in healthcare is changing. In her AI Prognosis newsletter she notes that the industry…
    STAT · 4mo agoPositive↗ source
  • Teva nabs experimental Tourette drug in $700M Emalex buyout
    A Jefferies analyst argued the deal — Teva’s largest in a decade — “makes sense” given the synergies between Emalex and the pharmaceutical giant’s neurology business.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • FDA moves to speed trials by reviewing AstraZeneca and Amgen data in real time, seeks public input on pilot program
    The U.S. Food and Drug Administration announced a new initiative aimed at making clinical trials faster and more efficient. As a first step, the agency will begin reviewing trial data in real time…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Health Secretary Kennedy moves to reverse FDA ban on peptide compounding, raising safety concerns
    Health Secretary Robert F. Kennedy Jr. is pushing to overturn a 2023 FDA rule that stopped compounding of certain peptides, a move that could reopen a market for products such as BPC-157 and GHK-Cu…
    STAT · 4mo agoRegulatoryNegative↗ source
  • FDA reports most U.S. infant formulas contain only trace or undetectable levels of heavy metals and other contaminants
    The Food and Drug Administration examined 312 samples drawn from 16 major infant‑formula brands, looking for residues of heavy metals, pesticides, PFAS and phthalates. Across the board the agency…
    STAT · 4mo agoRegulatoryPositive↗ source