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2,831 stories matching this filter · ← front page

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  • Oura expands into health services with launch of smaller Ring 5 wearable
    Oura announced the release of its new Ring 5, a smaller version of its popular health‑tracking ring. Alongside the hardware launch, the company said it will add features that let users link their…
    Endpoints · 5mo agoPositive↗ source
  • Former Legend Biotech co‑founder Frank Fan launches new venture at Wondercel Therapeutics
    Frank Fan, a co‑founder of Legend Biotech, moved from Nanjing to Shenzhen in 2022 in search of a fresh start. After leaving Legend abruptly, he assumed the role of chief executive officer at Wonde…
    Endpoints · 5mo agoPositive↗ source
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FDA delays AstraZeneca breast cancer drug camizestrant PDUFA date
The U.S. Food and Drug Administration has extended the PDUFA target date for AstraZeneca’s breast cancer candidate camizestrant, pushing the review timeline back by a few days. No new deadline was…
Endpoints · 5mo agoRegulatoryNeutral↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 5mo agoApprovalPositive↗ source
  • FDA issues warning letters to eight retailers for selling unauthorized tobacco products that mimic candy and other everyday items
    The U.S. Food and Drug Administration announced on May 20, 2026 that it has sent warning letters to eight retailers for offering unauthorized nicotine pouches and dissolvable tobacco products that…
    fda press · 5mo agoRegulatoryNegative↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • Acceleron veterans and Westlake back new IPF biotech Oorja Bio with $30 million Series A
    Entrepreneurs who previously brought the drug Winrevair to market have launched a new biotech, Oorja Bio, to target idiopathic pulmonary fibrosis, a hard-to-treat lung disease. The company announc…
    Endpoints · 5mo agoDealPositive↗ source
  • BioMarin's BMN-401 fails key endpoint in ENPP1 deficiency Phase 3 trial
    An experimental therapy, BMN 401, was tested in a Phase 3 study for ENPP1 deficiency, a rare disease. The drug missed one of its two co-primary endpoints, a result that regulators consider critical…
    BioPharma Dive · 5mo agoNegative readoutNegative↗ source
  • Novo Nordisk streamlines R&D to speed discovery, adds AI to integrated research teams
    Novo Nordisk's new CEO Maziar Mike Doustdar, who took the helm in the summer of 2025, announced a reorganization of the company's R&D structure. Jacob Sten Petersen, head of global research, expla…
    Endpoints · 5mo agoPositive↗ source
  • Full-Life Technologies secures $150M Series D financing
    Full-Life Technologies announced it has raised $150 million in a Series D financing round, comprising $110 million in the main tranche and an additional $40 million. The capital is intended to adv…
    Endpoints · 5mo agoDealNeutral↗ source
  • Relay Therapeutics' zovegalisib shows 60% response in mid‑stage trial for rare vascular anomalies
    Relay Therapeutics reported early data from a phase 2 trial of its experimental drug zovegalisib in patients with vascular anomalies, a group of rare disorders characterized by abnormal blood vesse…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • Relay Therapeutics' zovegalisib meets efficacy endpoint in Phase 2 vascular anomalies trial
    Relay Therapeutics reported that its PI3Kα inhibitor zovegalisib achieved the predefined efficacy threshold in a Phase 2 study of a rare genetic vascular anomaly. The data readout exceeded Wall Str…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • BioMarin's Phase 3 trial of ENPP1 enzyme therapy fails to show benefit
    BioMarin reported that its late-stage study of an enzyme replacement therapy for ENPP1 deficiency did not meet its primary efficacy endpoints. The trial, which enrolled patients lacking the ENPP1 e…
    Endpoints · 5mo agoNegative readoutNegative↗ source
  • Wave Life Sciences reports early-stage data showing monthly dosing possible for RNA editing therapy in AATD
    Wave Life Sciences announced an updated cut of data from its early-stage study of an RNA editing treatment aimed at alpha‑1 antitrypsin deficiency (AATD). The new data suggest the genetic therapy…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Nourish secures $100M funding, valuation climbs to $1.75B
    Nourish, a New York-based telehealth platform that connects patients with nutritionists, announced a fresh financing round. The round raised $100 million and lifted the company's valuation to abou…
    Endpoints · 5mo agoDealPositive↗ source
  • Paragon Therapeutics moves migraine-focused Mentari Therapeutics public via reverse merger
    Paragon Therapeutics, a hub-and-spoke biotech company, is taking its migraine drug subsidiary Mentari Therapeutics public through a reverse merger. The approach follows Paragon's prior use of reve…
    Endpoints · 5mo agoDealNeutral↗ source
  • TrumpRx expands catalog with over 600 additional generic drugs
    The White House announced that the TrumpRx direct‑to‑consumer platform has added a large batch of new generic medicines. The expansion brings the total number of generics available on the site to w…
    Endpoints · 5mo agoPositive↗ source
  • Health Tech team hosts consumer health discussions at FT US Pharma and Biotech Summit
    On Thursday, the Health Tech team led a series of conversations at the Financial Times’ US Pharma and Biotech Summit, an event organized in collaboration with Endpoints News. The sessions focused…
    Endpoints · 5mo agoNeutral↗ source
  • FDA approves AstraZeneca’s novel hypertension pill Baxfendy
    The U.S. Food and Drug Administration has cleared AstraZeneca’s new hypertension medication, Baxfendy, marking the first approval of a drug that works by inhibiting a blood‑pressure‑raising enzyme.…
    BioPharma Dive · 5mo agoApprovalPositive↗ source
  • Merck's China-sourced ADC shows survival benefit in Phase 3 endometrial cancer trial
    Merck & Co., in partnership with Chinese biotech Kelun-Biotech, reported that its experimental antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoint in a global Phase 3…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca’s baxdrostat for select hypertension patients
    AstraZeneca announced that the U.S. Food and Drug Administration has granted approval for its blood‑pressure pill baxdrostat, targeting a specific group of patients with hypertension. The approval…
    Endpoints · 5mo agoApprovalPositive↗ source
  • Amgen defends Tavneos as FDA, European regulators and Japanese doctors raise safety concerns
    Amgen said it continues to support its rare-disease therapy Tavneos despite recent safety alerts. The U.S. FDA has indicated it wants the drug removed from the market after a report of 20 deaths l…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in Japan
    The FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), poste…
    BioPharma Dive · 5mo agoRegulatoryNegative↗ source
  • Merck and Kelun-Biotech's ADC sac-TMT secures first global Phase 3 win ahead of schedule
    Merck and China-based Kelun-Biotech reported that their experimental antibody-drug conjugate sac-TMT achieved a positive outcome in a global Phase 3 study, marking the first such success for the ca…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Republican lawmaker releases FDA analysis of alleged pediatric Covid vaccine deaths
    A Republican congressman has made public an analysis that the FDA commissioned to examine claims of child deaths linked to Covid-19 vaccines. The study was initiated by former senior FDA officials…
    Endpoints · 5mo agoRegulatoryNeutral↗ source