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3,108 stories matching this filter · ← front page

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STAT1801Endpoints1402Fierce Biotech719BioSpace711BioPharma Dive529raps235onclive165fda recalls114
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  • Mirum's hepatitis D antibody brelovitug meets primary endpoint in phase 3 trial
    Mirum Pharmaceuticals announced that its experimental antiviral monoclonal antibody brelovitug achieved the primary efficacy goal in a phase 3 study for hepatitis D. The trial results continue a s…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • BIO proposes seven-point plan to keep US biotech ahead of China
    BIO, a major biotech lobbying organization, released a seven‑part “BioAdvance” action plan aimed at preserving U.S. leadership in biotechnology as China rolls out its own five‑year strategy. The p…
    BioPharma Dive · 2d agoRegulatoryPositive↗ source
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  • Democratic committee chairs send letters to 27 drugmakers demanding details on Trump-era MFN pricing agreements
    Incoming Democratic chairs of the Senate Finance Committee and the House Energy and Commerce, Ways and Means, and Education and Labor committees have issued a new round of letters to all 27 drugmak…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Former Eli Lilly sales rep sues, alleging termination after raising concerns over off-label promotion of Mounjaro for weight loss
    A former senior territory manager at Eli Lilly has filed a federal lawsuit claiming she was dismissed after reporting that the company was marketing its diabetes drug Mounjaro as a weight‑loss solu…
    STAT · 2d agoRegulatoryNegative↗ source
  • Start Center for Cancer Research launches Italy’s first early-phase oncology trial site with IFO
    Start Center for Cancer Research has opened its first early-phase cancer clinical trial site in Italy, partnering with the public research hospital group Istituti Fisioterapici Ospitalieri (IFO).…
    Fierce Biotech · 2d agoDealPositive↗ source
  • PepGen's Phase 2 DM1 Data Show 46% Average Splicing Correction, Shares Jump 163%
    PepGen reported results from the 10 mg/kg multiple‑ascending‑dose cohort of its ongoing Phase 2 Freedom2‑DM1 trial, testing PGN‑EDODM1, an oligonucleotide designed to correct the molecular defect i…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • London biotech Oyster raises $60 million to develop tau-targeting protein degraders
    Oyster Therapeutics, a London-based biotech, announced it has secured $60 million in an extension of its Series A financing round. The funding will support its lead program that uses a modified pr…
    BioPharma Dive · 2d agoDealPositive↗ source
  • Deerfield Management teams with AWS to boost AI-driven life-science ventures
    Deerfield Management announced a collaboration with Amazon Web Services aimed at accelerating AI-native healthcare and life-science companies in its portfolio. The agreement links AWS's generative…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Dutch regulators probe Biogen over exclusive MS test for Tysabri patients
    Dutch competition authority (ACM) has opened an investigation into Biogen concerning its handling of a blood test linked to its multiple sclerosis drug Tysabri. The probe focuses on whether Biogen…
    STAT · 2d agoRegulatoryNegative↗ source
  • PepGen reports promising early results for myotonic dystrophy type 1 drug in six-patient trial
    PepGen announced that its experimental therapy for myotonic dystrophy type 1 showed the most encouraging early data yet in a small study. The trial involved six patients who received the drug for 1…
    STAT · 2d agoPositive readoutPositive↗ source
  • Democratic wins in Texas, Georgia and Wisconsin could open Medicaid expansion for over a million residents
    Three of the ten states that have not yet expanded Medicaid may revisit their stance after recent Democratic gains in state elections. Texas, Georgia and Wisconsin saw power shifts that could make…
    STAT · 2d agoRegulatoryNeutral↗ source
  • AbCellera halts development of OX40 antibody ABCL575 after phase-1 trial
    AbCellera announced it will not move ABCL575 beyond phase 1, ending its OX40 program. The phase-1 study met its endpoints, showing a favorable tolerability profile and pharmacokinetics that suppor…
    Fierce Biotech · 2d agoNegative↗ source
  • Coherus Oncology cuts 30% of staff to focus on esophageal cancer combo
    Coherus Oncology announced another round of layoffs, reducing its workforce by about 30% as it narrows its development program. The cuts follow the presentation of phase 1b data on a combination o…
    Fierce Biotech · 2d agoLayoffsNeutral↗ source
  • Novocure's Optune Mya device denied FDA approval over efficacy concerns
    Novocure received a "not approvable" letter from the FDA for its Optune Mya system, which was being evaluated for patients with brain metastases from non‑small cell lung cancer after stereotactic r…
    Fierce Biotech · 2d agoRegulatoryNegative↗ source
  • Senators Wyden and Sanders unite on push to lower Medicare eligibility age by a decade
    Senate Finance Committee Chair Ron Wyden (D-Ore.) and Independent Senator Bernie Sanders (I-Vt.) said they are aligned on advancing a “Medicare for All” agenda. Sanders has proposed lowering the M…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Flu season this year appears to be affecting teens and young adults more severely, experts say
    The article notes that flu activity this year has already resulted in at least 1.7 million reported cases, and health experts are observing that teenagers and young adults are experiencing higher r…
    STAT · 2d agoNeutral↗ source
  • Experts warn AI health advice may be accurate yet lead to poorer outcomes
    Artificial intelligence now answers hundreds of millions of health questions each week, with tools like ChatGPT fielding queries from the public at an unprecedented scale. Government officials and…
    STAT · 2d agoNegative↗ source
  • Men turn to chatbots for therapy as earnings season unfolds
    The latest STAT Health Tech newsletter notes growing optimism about mental‑health chatbots, especially among men who are less likely to seek traditional therapy. It also recaps key points from the…
    STAT · 2d agoNeutral↗ source
  • PepGen soars on promising early data for muscular dystrophy drug
    While from a small study, the findings suggest PepGen’s therapy compares favorably to other RNA-based medicines in testing at Novartis and Dyne Therapeutics.
    BioPharma Dive · 1d ago↗ source
  • STAT+: GLP-1s are given an FDA warning for rare eye condition risk
    The FDA warned that GLP-1 drugs carry a potential risk of a rare but serious eye condition sometimes referred to as an “eye stroke.”
    STAT · 2d ago↗ source
  • FDA approves Bayer’s Sunharbo, first Factor XIa inhibitor to lower stroke recurrence risk
    The Food and Drug Administration has approved Bayer's new medication intended to prevent another stroke in patients who have already experienced one. The drug, sold under the brand name Sunharbo,…
    STAT · 2d agoApprovalPositive↗ source
  • FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
    FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a rec…
    fda press · 2d agoApprovalPositive↗ source
  • Bayer's Sunharbo receives FDA approval as first Factor XIa blood thinner
    FDA approved Bayer's new oral anticoagulant Sunharbo, marking the first U.S. approval of a Factor XIa inhibitor. The drug blocks Factor XIa, a protein that helps clots grow while playing a minor r…
    BioPharma Dive · 2d agoApprovalPositive↗ source
  • FDA warns GLP-1 weight-loss drugs may cause rare eye stroke condition
    The Food and Drug Administration issued a warning that GLP-1 drugs used for weight loss may be linked to a rare eye condition called non-arteritic anterior ischemic optic neuropathy, sometimes desc…
    STAT · 3d agoRegulatoryNegative↗ source
  • New evidence links gene‑therapy viral vectors to tumor formation in pediatric patients
    For years, scientists have debated whether the viral vectors used in gene therapy could cause cancer. Recent case reports now provide strong evidence that such a risk is real. The reports involve…
    STAT · 3d agoNegative readoutNegative↗ source