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22 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 · 7h agoNegative readoutNegative↗ source
  • 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
28
fda recalls22
fda press21
fda medwatch18
570
Vaccines516
Endocrinology & Metabolism290
Ophthalmology255
Infectious Disease253
Nephrology239
  • 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 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
  • 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
  • Braveheart files for IPO to fund Phase 3 of Hengrui's Cytokinetics rival
    Biotechs are sprinting to the IPO queue. In the industry's fourth IPO filing in two weeks, Braveheart Bio is seeking a Nasdaq listing to fuel Phase 3 testing of a cardio drug that could potentially…
    Endpoints · 16d ago↗ source
  • Updated: AstraZeneca sinks on unexpected heart drug trial failure
    AstraZeneca’s shares dropped in early trading Thursday after a heart disease treatment it is developing with Ionis Pharmaceuticals surprisingly failed in a late-stage trial. The companies had aimed…
    Endpoints · 22d ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 29d ago↗ source
  • Kardigan raises $400M in IPO to back three clinical-stage cardio drugs
    More evidence has arrived that biotech IPOs are alive and well: A cardiology drug developer with three clinical-stage candidates just secured $400 million for its Nasdaq debut slated for Thursday.…
    Endpoints · 1mo ago↗ source
  • Edgewise to advance heart drug into Phase 3 following mid-stage data update
    Edgewise Therapeutics has shared plans to advance its drug candidate for a genetic heart disease into a registrational study on the back of updated Phase 2 data. The biotech said Tuesday ...
    Endpoints · 1mo ago↗ source
  • Kardigan plans $320M IPO for heart drugs as Nasdaq listings gain steam
    Parabilis Medicines' record-breaking IPO will be a tough act to follow, but a drug developer with three late-stage cardio medicines is up for the challenge. It's led by a CEO who sold ...
    Endpoints · 1mo ago↗ source
  • REVELUTION-2 Trial Is Evaluating Cardiovascular Risk With Relugolix Plus Abiraterone Acetate in High-Risk Prostate Cancer
    Sagar A. Patel, MD, discusses the REVELUTION-2 trial evaluating cardiovascular safety with hormone therapy in prostate cancer.
    onclive · 2mo ago↗ source
  • Behind Galapagos’ transformation into Lakefront Biotherapeutics
    CHICAGO — From a 22nd-floor office overlooking the Chicago Riverwalk, in the heart of the Midwest hub’s white-collar downtown district, Lakefront Biotherapeutics’ executives hope to stage the compa…
    Endpoints · 2mo ago↗ source
  • Second Clinical Scenario - Progressive Disease Despite Hematocrit Control
    Polycythemia vera symptoms like fatigue and aquagenic itching signal active disease; experts urge objective tracking and tailored therapy beyond phlebotomy.
    onclive · 2mo ago↗ source
  • Braveheart Bio's Hengrui-licensed cardiac drug scores second clinical win
    Braveheart Bio said Monday that the heart muscle therapy it licensed from China’s Jiangsu Hengrui Pharmaceuticals has succeeded in a mid-stage trial for the same condition in which Cytokinetics rec…
    Endpoints · 2mo ago↗ source
  • Transformational Utah Investment in Artificial Intelligence and Computing to Advance Health and Discovery
    The State of Utah has made a visionary investment in AI and advanced computing infrastructure to advance research.
    onclive · 2mo ago↗ source
  • Clinical Scenario Presentation and Treatment Approach for Progressive Disease
    Experts weigh mutation testing, comorbidities, and patient preference to guide second-line CLL options after BTK inhibitor resistance.
    onclive · 2mo ago↗ source
  • The Type of Fat—Not the Amount—Fuels Pancreatic Cancer
    Research from Yale Cancer Center showed that the type of fat consumed may matter more than amount in pancreatic cancer.
    onclive · 2mo ago↗ source
  • Cytokinetics succeeds where Bristol Myers failed in heart muscle disease
    Cytokinetics’ pill for a heart muscle disorder called hypertrophic cardiomyopathy could see its addressable market double after it succeeded in a pivotal trial for another form of the disease. The…
    Endpoints · 2mo ago↗ source
  • AbbVie faces questions about Skyrizi competition from J&J
    Threats to AbbVie's immunology dominance took center stage on the company's first-quarter earnings call Wednesday morning, as analysts pressed executives on their defense strategy. The heart of the…
    Endpoints · 3mo ago↗ source
  • Pfizer delays patent cliff for blockbuster Vyndamax
    Pfizer is staving off Vyndamax competition for another two years. The drug, also known as tafamidis, is among Pfizer’s top three best-selling medicines and vaccines. Vyndamax is approved for a hear…
    Endpoints · 3mo ago↗ source
  • Novartis CEO disheartened by Germany’s planned €60B cuts to healthcare spending
    Novartis CEO Vas Narasimhan said the Swiss company is “very disappointed” by Germany’s plan to shave off more than €60 billion in healthcare costs that would affect pharma sales. Germany wants to s…
    Endpoints · 3mo ago↗ source