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  • Entrada Therapeutics shares plunge after Duchenne trial shows modest dystrophin increase
    Entrada Therapeutics reported early data from a Phase 1/2 study of its RNA‑based therapy ENTR‑601‑44 for Duchenne muscular dystrophy, noting favorable safety and tolerability. The trial showed a d…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • Political appointee stalls Sanofi drug approval, raising concerns about FDA interference
    STAT's D.C. Diagnosis newsletter reports that a political appointee is impeding the approval of a Sanofi drug, suggesting direct political interference at the FDA. The article notes that the appoi…
    STAT · 4mo agoRegulatoryNegative↗ source
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  • Blackstone invests $250 million in Anagram to address cystic fibrosis complication
    Blackstone Life Sciences announced a $250 million investment in Anagram, a biotech focused on cystic fibrosis complications. The funding is part of one of the largest private investment funds in t…
    Endpoints · 4mo agoDealPositive↗ source
  • Entrada's Duchenne drug shows disappointing early data, shares tumble
    Entrada disclosed initial results from a low‑dose version of its exon‑44 skipping therapy for Duchenne muscular dystrophy. The data, collected from six patients, failed to meet the company’s expect…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Amgen invests $300 million in Puerto Rico biologics plant as Novartis plans to close German oral drug factory
    Amgen announced an additional $300 million investment in Puerto Rico to expand its biologics manufacturing capacity in Juncos, building on earlier commitments. The funding will be used to upgrade…
    Endpoints · 4mo agoDealNeutral↗ source
  • Sanofi asks FDA to withdraw teplizumab from fast-track review after internal disagreement
    Sanofi has formally requested that the U.S. Food and Drug Administration remove its type 1 diabetes therapy, teplizumab, from the agency's new speedy review program. The request follows a disagree…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Atara and Pierre Fabre's T-cell therapy gets new chance for FDA approval after twice rejected
    Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have received notice from the U.S. FDA that it will reconsider a previously rejected T-cell therapy. The therapy, which had been turned down…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Astellas reports promising early results for stem cell eye therapy ASP7317 in age-related disease
    Astellas announced data from an early-stage trial of ASP7317, a stem cell-derived therapy aimed at an age-related eye condition. The study showed encouraging signs of efficacy and safety in most p…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Roche to acquire digital pathology firm PathAI in deal potentially worth over $1B
    Roche plans to offer PathAI’s tools as part of an effort to improve cancer diagnosis and tailored treatment.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • FDA reexamines previously rejected rare cancer therapy amid claims of political interference
    The FDA has opened a new review of a treatment for a rare form of cancer that it had turned down a few months earlier. The reconsideration arrives as the agency faces fresh allegations that politi…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • AI-generated fake citations surge, study finds they are polluting scientific literature
    A new study published in The Lancet reports a sharp rise in fabricated citations that do not correspond to real papers, threatening the reliability of the scientific record. The researchers found…
    STAT · 4mo agoNegative↗ source
  • WHO briefs on hantavirus outbreak aboard cruise ship, Spain to allow docking in Canary Islands
    WHO held a press conference Thursday to update on a suspected hantavirus outbreak on the cruise ship MV Hondius. The vessel is expected to dock in Tenerife, Canary Islands, after Spain agreed to t…
    STAT · 4mo agoNeutral↗ source
  • Seaport Therapeutics goes public as obesity drug race heats up and FDA commissioner faces White House scrutiny
    Seaport Therapeutics announced a successful initial public offering, with CEO Daphne Zohar discussing the company’s next steps on the latest Readout LOUD podcast. The episode also highlighted the…
    STAT · 4mo agoNeutral↗ source
  • Health insurers grapple with profit cuts after a costly 2025, outlook for 2026 remains uncertain
    In 2025, a wave of health insurers reduced or withdrew their profit forecasts after being hit by rising medical expenses. The cost pressures stemmed from higher drug prices, increased utilization…
    Endpoints · 4mo agoNegative↗ source
  • Amazon Pharmacy adds Ozempic pill to its same-day prescription kiosks
    Amazon Pharmacy announced that its same-day prescription kiosks will now dispense the Ozempic tablet, expanding the range of drugs available through the vending-style machines. The kiosks, which h…
    Endpoints · 4mo agoNeutral↗ source
  • Study finds researchers become less disruptive as they age, favoring incremental work
    A new study published in Science reports that scientists tend to produce their most disruptive work early in their careers, but shift toward less groundbreaking research as they get older. The ana…
    STAT · 4mo agoNeutral↗ source
  • CDC’s cruise ship health chief Luis Rodríguez retires amid hantavirus outbreak on MV Hondius
    The Centers for Disease Control and Prevention announced that Luis Rodríguez, who has been with the Vessel Sanitation Program since 2010 and its chief since 2023, will retire. His departure comes…
    STAT · 4mo agoNeutral↗ source
  • Pennsylvania files lawsuit against Character.AI for presenting chatbot as licensed physician
    The Commonwealth of Pennsylvania has filed a lawsuit against Character.AI, a startup that offers users the ability to converse with AI-generated personas. The suit alleges that the company illegall…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • STAT Health Tech newsletter highlights OpenAI health policy ideas and Dexcom CGM updates
    The latest STAT Health Tech newsletter, edited by Mario Aguilar, offers a roundup of recent technology developments in health care. OpenAI proposes a set of health policy recommendations aimed at…
    STAT · 4mo agoNeutral↗ source
  • STAT+: FDA to reconsider treatment for rare cancer after its surprise rejection
    The companies developing Ebvallo reached an agreement with the FDA to address its main reason for rejecting the drug.
    STAT · 4mo ago↗ source
  • Hospital shootings steadily increased since 2000
    What the FDA has lost, why hantavirus isn't the next pandemic, and more health news from Morning Rounds
    STAT · 4mo ago↗ source
  • STAT+: Next-gen Duchenne drug from Entrada disappoints
    A next-gen Duchenne therapy from Entrada Therapeutics fell short in an early study, as a number of companies race to make improved drugs.
    STAT · 4mo ago↗ source
  • Angelini fortifies neurology portfolio with $4.1B buyout of Catalyst
    Angelini Pharma is spending $4.1 billion to buy Catalyst Pharmaceuticals and its trio of FDA-approved treatments for rare neurological diseases. The buyout will add three medicines to Angelini’s po…
    Endpoints · 4mo ago↗ source
  • STAT+: Color me skeptical: Drinking gold is not an ALS cure
    In this week's Biotech Scorecard newsletter, Adam Feuerstein takes on the company touting gold microdust suspended in water as an ALS treatment.
    STAT · 4mo ago↗ source
  • STAT+: Angelini Pharma buys Catalyst Pharmaceuticals and its rare disease drugs for $4.1B
    The Italian firm Angelini Pharma is buying Catalyst Pharmaceuticals, the maker of rare disease drugs, for $4.1 billion.
    STAT · 4mo ago↗ source