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3,171 stories matching this filter · ← front page

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  • Edgewise Therapeutics' experimental heart drug meets Phase 2 endpoints in cardiomyopathy trial
    Edgewise Therapeutics reported that its oral candidate EDG-7500 achieved the predefined goals of a Phase 2 study in both obstructive and non‑obstructive hypertrophic cardiomyopathy. The trial demo…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Medicare to Cover Obesity Drugs for Adults 65+ Starting Next Month
    Medicare will begin covering prescription weight‑loss medications for beneficiaries aged 65 and older starting next month, marking the first time the program includes such drugs. The coverage is p…
    STAT · 2mo agoRegulatoryPositive↗ source
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  • FDA gives modest backing to Moderna’s flu vaccine, noting efficacy questions but no major concerns
    The FDA released briefing documents ahead of an advisory committee meeting on Moderna’s seasonal influenza vaccine. The agency’s assessment was described as tepid, highlighting some questions abou…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA approves Colorado plan to import lower-cost drugs from Canada
    The U.S. Food and Drug Administration issued a letter confirming that Colorado may move forward with a pilot program to bring prescription medicines from Canada. The proposal aims to lower drug co…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • Biotech Converts Failed Trial Data into AI Model
    A biotech startup recently faced a setback when a clinical trial did not achieve its primary goals. Rather than discarding the results, the company chose to analyze the data for new insights. The…
    STAT · 2mo agoPositive↗ source
  • Express Scripts and PCMA file lawsuits to block Tennessee FAIR Rx Act targeting PBM-owned pharmacies
    Express Scripts, a Cigna subsidiary, and the Pharmaceutical Care Management Association have filed separate lawsuits in federal court in Tennessee. The suits challenge the FAIR Rx Act, a law passe…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • FDA staff raise concerns over data for Moderna’s mFlusiva flu vaccine ahead of advisory panel
    FDA staff have examined the evidence for Moderna's mFlusiva, an mRNA flu vaccine, and highlighted shortcomings in the data submitted to the agency. The Food and Drug Administration will convene an…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • Edgewise Therapeutics moves heart disease drug into Phase 3 after updated Phase 2 data
    Edgewise Therapeutics announced on June 16, 2026 that it will advance its investigational therapy for a genetic heart disease into a registrational Phase 3 trial. The decision follows an updated a…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Eli Lilly acquires another pain biotech, its 11th deal this year, as FDA eyes decision on once‑weekly PrEP pill
    Eli Lilly announced the purchase of an Austin, Texas‑based pain biotechnology company, marking the 11th acquisition the Indianapolis‑based firm has completed in 2026. The deal expands Lilly's portf…
    Endpoints · 2mo agoDealNeutral↗ source
  • Verge Labs launches AI tool to boost patient enrollment and trial efficiency; Moderna appoints new chief commercial officer
    Verge Labs announced a new artificial‑intelligence model designed to identify patients most likely to respond to a therapy, aiming to reduce dropout rates and increase the statistical power of clin…
    STAT · 2mo agoPositive↗ source
  • Verge Labs launches AI tool to improve neurology trial patient selection after ALS setback
    Verge Labs, formerly known as Verge Genomics, announced a new artificial intelligence model designed to address patient stratification challenges in neurology clinical trials. The company says the…
    STAT · 2mo agoPositive↗ source
  • Congress urged to swiftly reauthorize Pandemic and All-Hazards Preparedness Act
    Former assistant secretary for preparedness Craig Vanderwagen and former Senate staffer Jennifer Alton argue that the Pandemic and All-Hazards Preparedness Act needs prompt reauthorization. They no…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Health groups accuse HHS of rushing reinstatement of CDC vaccine advisory panel
    A coalition of health organizations has publicly charged the U.S. Department of Health and Human Services with attempting to accelerate the return of the CDC's Advisory Committee on Immunization Pr…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • UCSF spinout Kopra Bio secures $9.1M to advance virus therapy for glioblastoma in China
    Kopra Bio, a biotechnology company spun out of the University of California, San Francisco, announced it has raised $9.1 million in financing. The capital will be used to move its experimental viru…
    Endpoints · 2mo agoDealPositive↗ source
  • Be Bio halts hemophilia B cell-editing therapy trial
    Be Bio announced that it has terminated its clinical study of a hemophilia B therapy that used gene-editing of a patient’s own cells. The termination was recorded in a federal clinical-trials regi…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • U.S. infant mortality hits record low in 2025, though still behind peer nations
    Preliminary CDC data show the United States recorded its lowest infant mortality rate ever in 2025. The rate fell to just under 5.4 deaths per 1,000 live births. That figure represents a modest de…
    STAT · 2mo agoPositive↗ source
  • US spends $360,000 storing contraceptives meant for African aid, with most supplies nearing expiration
    The U.S. government spent roughly $360,000 between January 2025 and March 2026 to keep millions of dollars worth of contraceptives in climate-controlled storage, according to a recent USAID Office…
    STAT · 2mo agoNeutral↗ source
  • Human Cell Atlas leadership ties to 10x Genomics spark conflict-of-interest concerns
    The International Human Cell Atlas Consortium is marking its 10-year anniversary with a meeting in Boston that brings together academic and industry leaders. Attention has turned to one of the pro…
    STAT · 2mo agoNegative↗ source
  • OpenLoop Health says it can launch a virtual GLP-1 prescribing service in 24 hours
    OpenLoop Health says it can set up a telehealth operation that can prescribe GLP-1 medicines within a day. The company provides the medical‑group infrastructure that powers multiple virtual care p…
    Endpoints · 2mo agoNeutral↗ source
  • Alzheimer specialist admits she missed early signs in her own father, urging earlier detection
    A neurologist at the University of California, San Diego writes about her personal experience when her father began showing subtle cognitive changes that were missed. She recounts small mistakes a…
    STAT · 2mo agoNegative↗ source
  • Medicare to cover GLP-1 weight-loss drugs for seniors under temporary Trump-backed program
    Starting July 1, Medicare will make GLP-1 weight-loss drugs available to adults 65 and older at a cost of $50 per prescription through a new demonstration program. The initiative, called Bridge, i…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Medicare rule could bring subcutaneous Keytruda and Opdivo under price negotiations
    A federal rule proposed for 2029 aims to close a loophole that currently shields medicines moving from intravenous to subcutaneous administration from Medicare price negotiations. The Centers for M…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • J&J's Talvey plus Darzalex Faspro cuts death risk by up to 53% in relapsed multiple myeloma
    Johnson & Johnson reported that a combination of its immunotherapy Talvey with Darzalex Faspro, with or without Pomalyst, significantly lowered the risk of death in patients with relapsed or refrac…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Newborn contracts preventable syphilis amid Pfizer emergency penicillin shortage and procedural delays
    In March 2026 a pregnant woman in Gila County, Arizona tested positive for syphilis. Doctors said she needed an injectable penicillin dose at least 30 days before delivery to avoid severe fetal com…
    STAT · 2mo agoRegulatoryNegative↗ source
  • CMS proposes rule to close Medicare negotiation loophole for biologics
    CMS announced a proposed policy change that would clarify how the Centers for Medicare & Medicaid Services groups products for price negotiations under the Inflation Reduction Act. The rule target…
    Endpoints · 2mo agoRegulatoryNeutral↗ source