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167 stories matching this filter · ← front page

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  • Novo Nordisk's late-stage anti-inflammatory heart drug fails Phase 3 trial
    Novo Nordisk announced that its experimental anti-inflammatory compound designed to target cardiovascular inflammation did not meet its primary endpoint in a Phase 3 trial. The study was intended…
    Endpoints · 4h agoNegative readoutNegative↗ source
  • Novo Nordisk's anti-inflammatory drug ziltivekimab fails to cut major heart events in Phase 3 trial
    Novo Nordisk reported that its investigational anti‑inflammatory antibody, ziltivekimab, did not reduce the incidence of major cardiovascular events in a pivotal Phase 3 study. The trial enrolled…
    STAT · 7h agoNegative readoutNegative↗ source
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fda recalls22
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570
Vaccines516
Endocrinology & Metabolism290
Ophthalmology255
Infectious Disease253
Nephrology239
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 1d agoRegulatoryNegative↗ source
  • FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs
    The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA advisory panel advises against approving Capricor’s Duchenne cell therapy, deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee convened to evaluate deramiocel, a cell‑based treatment for Duchenne muscular dystrophy developed by Capricor Therapeutics. Capricor…
    STAT · 2d agoRegulatoryNegative↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 3d agoRegulatoryNeutral↗ source
  • ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions
    The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…
    STAT · 2d agoNegative↗ source
  • STAT+: Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug
    Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
    STAT · 4d agoRegulatoryNeutral↗ source
  • STAT+: Fatal gene-editing trial in China raises ethics and oversight questions
    Sanofi insulin pen in short supply, a win for peptide compounds, and more biotech news from The Readout
    STAT · 7d ago↗ source
  • FDA panel confronting peptide controversy
    Today's biotech news features the FDA weighing the fate of peptides; approvals for RevMed, GSK; and data on Lilly's "triple-G."
    STAT · 8d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Lilly obesity drug data, a push for FDA to ban DTC ads, and more
    A study of Lilly's retatrutide weight loss drug in people with heart disease did not answer a crucial question — whether it reduces cardiovascular risk
    STAT · 8d ago↗ source
  • STAT+: New data on Eli Lilly’s ‘triple-G’ drug leave open questions on heart benefit
    On analyses that looked at major cardiovascular events, those taking retatrutide did not have a significant lower risk of death, heart attack, or stroke.
    STAT · 8d ago↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 9d ago↗ source
  • Opinion: STAT+: I’m a cardiologist. I’m not sure the new cholesterol drug enlicitide is a game-changer
    “In truth, I don’t anticipate prescribing patterns changing immediately,” cardiologist Vishal Khetpal writes of the new cholesterol drug Lipfendra.
    STAT · 9d ago↗ source
  • HHS vaccine committee quietly gets new charter
    Lax clinical oversight for online GLP-1 prescriptions, proposed financial help for people who want to quit smoking, and more health news
    STAT · 11d ago↗ source
  • Opinion: My husband’s suicide shows there’s something very wrong with the U.S. insurance industry
    “My love for Randy and my professional experience were not enough to save him,” a physician writes about her husband’s suicide.
    STAT · 11d ago↗ source
  • Opinion: Beware the unintended consequences of testosterone screening for military servicemembers
    “I fear that the widespread rollout of testosterone screening may lead to some surprising and unintended consequences,” writes a urologist who studies testosterone.
    STAT · 12d ago↗ source
  • Opinion: STAT readers on the value of primary care, obesity as a disease, and more
    “The real opportunity is to move beyond policies and narratives that pit specialties against one another,” presidents of the AAFP, ACP, and AAP write.
    STAT · 13d ago↗ source
  • Opinion: What the 20th-century war on smog tells us about today’s wildfire smoke
    The evolution of air pollution policy shows how to respond to the dangerous haze caused by Canadian wildfires, experts write in opinion piece.
    STAT · 13d ago↗ source
  • FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
    The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…
    fda press · 14d ago↗ source
  • STAT+: Fresh turmoil roils American Diabetes Association following controversy at conference
    Turmoil at the ADA has taken a fresh turn, with leaders blocking editors at its flagship journal from publishing pieces detailing a controversy at the group’s annual meeting.
    STAT · 14d ago↗ source
  • STAT+: Medicare wants to shake up how it pays for clinical AI
    In this edition of STAT Health Tech: Centers for Medicare and Medicaid Services proposes major changes to RPM, clinical AI payment models.
    STAT · 15d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Kalshi bets on clinical trials, a Merck cholesterol pill, and more
    Kalshi, one of the world’s largest prediction market exchanges, plans to take bets on clinical trials and regulatory approvals
    STAT · 15d ago↗ source
  • Opinion: The growing fang-to-pharmacy pipeline
    “Some of the most powerful medicines we will ever find are already here, carried in the fangs, stingers, and saliva of creatures we’ve been taught to fear,” writes Steve Midway.
    STAT · 15d ago↗ source