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  • Former FDA commissioner sees hope for stability under new acting leader Kyle Diamantas
    At a recent STAT Breakthrough Summit West, former FDA commissioner David Kessler addressed concerns about the agency’s recent turmoil and staff departures. Kessler said the appointment of acting c…
    STAT · 3mo agoRegulatoryPositive↗ 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 · 3mo agoNegative readoutNegative↗ source
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fda recalls67
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  • 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 · 3mo 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 · 3mo agoDealNeutral↗ source
  • Relay Therapeutics reports promising Phase 2 results for zovegalisib; Eli Lilly leads R&D performance ranking
    Relay Therapeutics announced positive Phase 2 data for its experimental drug zovegalisib, which targets rare diseases that cause abnormal blood vessel development. The company said the results were…
    STAT · 3mo agoPositive readoutPositive↗ 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 · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly Leads Both Innovation and Invention Rankings in Pharma R&D Performance
    STAT+ reports that Eli Lilly captured the top positions in a prominent pharma R&D performance ranking, leading both the innovation and invention categories. The rankings, compiled by UK-based IDEA…
    STAT · 3mo agoPositive↗ 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 · 3mo 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 · 3mo agoNegative readoutNegative↗ source
  • Over 1 in 8 U.S. Pregnant Women Report Alcohol Use, Raising Fetal Health Concerns
    More than one in eight pregnant adults in the United States reported drinking in the past month, according to STAT's analysis of 2024 government data, making alcohol use more common than gestationa…
    STAT · 3mo agoNegative↗ source
  • UK adopts tobacco-free generation law, mirroring Massachusetts policy
    The United Kingdom has passed a tobacco‑free generation law that bars retailers from selling cigarettes, vapes or nicotine pouches to anyone born on or after Jan. 1, 2009. Existing customers may co…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Heart transplant patient warns of 'ghost approval' gap that leaves life-saving drugs out of reach
    A heart transplant recipient and patient advocate describes how the medication everolimus (Zortress) is essential to prevent organ rejection, not an optional treatment. The author coins the term "…
    STAT · 3mo agoNegative↗ source
  • Trump-era foreign aid cuts likely hampered Ebola detection and response in Congo
    The United States reduced funding for programs that help prevent and control infectious diseases in the Democratic Republic of Congo during the final months before a fast-moving Ebola outbreak, acc…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Out-of-network spine surgery bills soar to $34,000 under No Surprises Act arbitration
    A new analysis shows that the median price for a lumbar laminectomy, a common spine surgery, is about $1,400 when performed by in-network providers. When the same procedure is done by out-of-netwo…
    STAT · 3mo agoRegulatoryNegative↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoPositive↗ source
  • Study finds many Canadian medical societies lack robust conflict-of-interest policies
    A new analysis of 68 Canadian medical societies shows that just under half have comprehensive conflict-of-interest policies. The researchers identified that 35 societies, or about 52%, do not addre…
    STAT · 3mo agoNegative↗ source
  • TrumpRx expands generic drug lineup through partnership with Mark Cuban, Amazon Pharmacy and GoodRx
    TrumpRx said it is adding a range of generic medicines to its portfolio after striking a deal that includes Mark Cuban, Amazon Pharmacy and GoodRx. The agreement is expected to broaden the company…
    STAT · 3mo agoDealNeutral↗ source
  • Dexcom CEO discusses future applications of continuous glucose monitors and provides updates on WiSeR and Epic market share
    Dexcom's chief executive spoke about potential new uses for the company's continuous glucose monitoring technology, suggesting that the device could play a broader role in health management beyond…
    STAT · 3mo agoNeutral↗ source
  • Former Stanford President Marc Tessier-Lavigne Addresses Allegations in New Book
    Former Stanford President Marc Tessier-Lavigne, now chief executive of AI drug‑discovery startup Xaira, spoke publicly for the first time at the STAT Breakthrough Summit West in San Francisco. Dur…
    STAT · 3mo agoNeutral↗ source
  • U.S. imposes 30‑day travel ban on travelers from DRC, Uganda, South Sudan amid Ebola outbreak
    The CDC announced a new order that bars anyone who has been in the Democratic Republic of the Congo, Uganda, or South Sudan within the past 21 days from entering the United States. The restriction…
    STAT · 3mo agoRegulatoryNeutral↗ 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 · 3mo 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 · 3mo agoApprovalPositive↗ source