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22 stories matching this filter · ← front page

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STAT967Endpoints742BioPharma Dive283BioSpace181Fierce Biotech172onclive165globenewswire health73raps
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allOncology5621Rare Disease1252Cardiology1054Hematology940Immunology932Vaccines816Pulmonology
  • Braveheart Bio raises $383 million in Nasdaq IPO to advance Hengrui cardiovascular drug to Phase 3
    Braveheart Bio, a U.S. biotech spun out of China’s Hengrui Pharmaceuticals, completed an initial public offering on the Nasdaq. The offering generated about $383 million in gross proceeds, providi…
    Endpoints · 10d agoDealPositive↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda recalls · 10d agoCRLNegative↗ source
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fda recalls41
fda medwatch32
fda press25
782
Psychiatry & CNS691
Ophthalmology347
Pain342
Endocrinology & Metabolism340
Infectious Disease331
  • 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 · 16d 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 · 17d agoPositive readoutPositive↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 25d agoRegulatoryPositive↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 1mo agoApprovalPositive↗ source
  • Braveheart Bio seeks Nasdaq listing to finance Phase 3 trial of Hengrui rival cardio drug
    Braveheart Bio announced it has filed for an initial public offering on the Nasdaq exchange. The company says the capital raised will be used to fund a Phase 3 study of its cardiovascular candidate…
    Endpoints · 1mo agoNeutral↗ 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 · 1mo 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 · 2mo 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 · 2mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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