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2,262 stories matching this filter · ← front page

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  • Beam Therapeutics reports year-long reduction in sickle cell crises in phase 1/2 risto-cel study
    Beam Therapeutics disclosed data from its phase 1/2 trial of risto-cel, a base-edited autologous cell therapy targeting the BCL11A gene in sickle cell disease. The trial enrolled 31 adults and ado…
    Fierce Biotech · 10h agoPositive readoutPositive↗ source
  • Bayer's asundexian receives FDA approval for stroke prevention
    Bayer announced that the U.S. Food and Drug Administration has approved its oral anticoagulant asundexian for stroke prevention. The drug is indicated to lower the risk of subsequent stroke in pati…
    Endpoints · 1d agoApprovalPositive↗ source
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Nephrology760
  • Oura to buy AI virtual care firm Counsel Health for $625 million, expanding in-app health services
    Oura, known for its smart ring and health tracking, announced it will acquire Counsel Health, an AI-driven virtual primary-care provider, for $625 million in cash. The acquisition is slated to clo…
    Fierce Biotech · 9h agoDealPositive↗ source
  • AstraZeneca acquires Omniose to boost bacterial vaccine capabilities
    AstraZeneca has completed the purchase of Omniose, a specialist in vaccine bioconjugation, making the company a wholly owned subsidiary of its infectious disease division. The two firms began coll…
    Fierce Biotech · 14h agoDealPositive↗ source
  • 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 · 14h agoPositive readoutPositive↗ source
  • Mirum readies FDA filing after positive Phase 3 results for hepatitis D therapy
    Mirum Pharmaceuticals announced that its hepatitis D candidate has met its primary goals in the second of two pivotal studies. The company said the data support moving the product toward regulatory…
    Endpoints · 4h agoPositive readoutPositive↗ source
  • Beam Therapeutics' base-edited sickle cell therapy shows success in Phase 1/2 trial
    Beam Therapeutics announced on Tuesday that its base-edited gene therapy for sickle cell disease met its primary endpoints in a Phase 1/2 study. The trial demonstrated that a single administration…
    Endpoints · 7h agoPositive readoutPositive↗ source
  • PepGen reports positive Phase 2 data for PGN-EDODM1 in myotonic dystrophy
    PepGen disclosed that its experimental oligonucleotide therapy PGN-EDODM1 showed encouraging early signals in a Phase 2 cohort of patients with myotonic dystrophy type 1 (DM1). The company said the…
    Endpoints · 8h agoPositive readoutPositive↗ 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 · 13h agoPositive readoutPositive↗ source
  • London startup Oyster Therapeutics raises $60M to develop oral tau degraders for Alzheimer’s
    Oyster Therapeutics, a London‑based biotech, announced it has closed a $60 million Series A‑2 financing round. The round was led by 4BIO Capital, a life‑science venture capital firm, with addition…
    Endpoints · 17h 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 · 20h agoDealPositive↗ source
  • Democrats demand unredacted drug pricing agreements from pharma firms after midterm victories
    Congressional Democrats have intensified scrutiny of pharmaceutical pricing agreements made under the previous administration. On Monday they sent letters to every drug maker that entered a most f…
    Endpoints · 7h agoRegulatoryNeutral↗ source
  • White House pushes Heidi Overton nomination for FDA commissioner as confirmation window narrows
    The White House is actively promoting Heidi Overton's nomination to become the commissioner of the Food and Drug Administration. Administration officials are working to gather sufficient Senate su…
    Endpoints · 8h 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 · 19h 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 · 20h 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 · 21h agoRegulatoryNegative↗ source
  • OpenAI’s health chief envisions ChatGPT Health moving patients from answers to actionable steps
    Nate Gross, who leads the health division at OpenAI, spoke at an Endpoints News health briefing about the company’s next steps for its AI health offering. He said the goal is to evolve ChatGPT Hea…
    Endpoints · 10h agoPositive↗ source
  • HHS Secretary RFK Jr. stays optimistic about Make America Healthy Again initiative despite midterm setbacks
    HHS Secretary Robert F. Kennedy Jr., who leads the Make America Healthy Again (MAHA) effort, addressed lawmakers on Capitol Hill this week. Throughout the year, industry observers have debated his…
    Endpoints · 2h agoPositive↗ source
  • Employers and consumers poised to reshape healthcare, says Health Tech Day discussion
    Last week the organizers held their second Health Tech Day, featuring an in‑person happy hour in New York and a live virtual stream for remote attendees. The forum focused on how employers and con…
    Endpoints · 8h agoNeutral↗ source
  • Family Farmstead Dairy recalls all cheddar cheese over possible Listeria contamination
    Family Farmstead Dairy announced a recall of all its cheddar cheese products because they may be contaminated with Listeria monocytogenes. Listeria can cause serious infections, especially in youn…
    fda recalls · 19h agoRegulatoryNegative↗ source
  • Oura to buy AI care startup Counsel Health for $625M
    Wearable ringmaker Oura is buying AI primary care startup Counsel Health. Oura is paying $625 million in cash for Counsel, which offers medical AI services as well as virtual visits with doctors. T…
    Endpoints · 5h ago↗ source
  • Laub's Feeding & Cubing, Inc. Voluntary Recalls Grade A Mini Hay Cubes Because of Potential Clostridium Botulinum Contamination
    Laub’s Feeding and Cubing, Inc. of Beryl, Utah is voluntary recalling up 89 ton of Grade A Mini Hay Cubes sold from October 3 – October 31 because the product has the potential to be contaminated w…
    fda recalls · 19h ago↗ 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 · 1d agoApprovalPositive↗ source
  • Delix Therapeutics raises $100M Series C to advance non-hallucinatory psychedelic for depression
    Delix Therapeutics announced a $100 million Series C financing round, led by Johnson & Johnson’s venture arm JJDC and joined by investors such as SV Health Investors’ Dementia Discovery Fund, RA Ca…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Windward Bio targets $204M Nasdaq IPO to fund Chinese respiratory drug program
    Windward Bio, a biotech backed by Sanofi, announced plans to go public on Nasdaq with an offering of 10.3 million shares priced between $16 and $18 each. The company expects net proceeds of about $…
    Fierce Biotech · 1d agoDealNeutral↗ source