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  • FDA approves Takeda’s orexin receptor agonist for narcolepsy, opening new drug class
    The FDA has granted approval to Takeda's novel narcolepsy medication, the first orexin receptor agonist to receive clearance. The twice‑daily pill, marketed as Orzeyful, is indicated for narcoleps…
    STAT · 16d agoApprovalPositive↗ source
  • LifeMine Therapeutics secures $188 million Series E funding from Gates, Bezos and others
    LifeMine Therapeutics, a Massachusetts biotech, recently completed a $188 million Series E round, attracting billionaire investors Bill Gates and Jeff Bezos. The funding follows a $75 million Seri…
    Fierce Biotech · 16d agoDealPositive↗ source
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Psychiatry & CNS724
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Endocrinology & Metabolism389
Infectious Disease361
  • Erica Schwartz confirmed as CDC director, ending year-long vacancy
    Erica Schwartz was confirmed on Wednesday as the director of the Centers for Disease Control and Prevention, ending a vacancy that lasted almost a year. The Senate approved her appointment by a 51-…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Emergent BioSolutions cuts 93 jobs and eliminates chief medical officer role in new restructuring plan
    Emergent BioSolutions announced a new round of restructuring aimed at aligning the company with current business realities, disclosed alongside its second‑quarter earnings. The plan includes layin…
    Fierce Biotech · 16d agoLayoffsNegative↗ source
  • Medicare GUARD pilot faces biotech push to spare rare disease drugs as Moderna begins first-in-human Ebola vaccine trial
    The Medicare Part D GUARD pilot, designed to lower retail drug prices, is under scrutiny because excluding rare disease medicines would erase most of the projected savings, according to STAT. Biot…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Fecal microbiome transplant boosts peanut tolerance sixfold in early trial
    Researchers at Boston Children’s Hospital conducted a small open‑label phase 1 trial in which 15 adult participants received oral encapsulated fecal microbiome transplantation to test safety and ef…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Novo Nordisk CFO describes roller-coaster growth and stays optimistic about CagriSema after Q2 earnings
    Novo Nordisk CFO Karsten Munk Knudsen talked to Fierce after the company released its second-quarter earnings, reflecting on his nine-year tenure and the firm’s volatile performance. He recalled a…
    Fierce Biotech · 17d agoEarningsNeutral↗ source
  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 17d agoNegative↗ source
  • Excluding orphan drugs from Medicare pricing pilots could erase most savings, analysis shows
    A Harvard researcher has calculated that removing rare disease treatments from two Medicare pilot programs-GLOBE and GUARD-would dramatically cut the projected cost savings. The pilots are designe…
    STAT · 17d agoRegulatoryNeutral↗ source
  • Attovia Therapeutics raises $289 million in IPO to fund anti-itch drug development
    Attovia Therapeutics completed an initial public offering that generated $289 million in gross proceeds. The company sold 17 million shares at $17 each, exceeding its original target of $182.4 mill…
    Fierce Biotech · 17d agoDealPositive↗ source
  • Federal regulators hold closed-door meetings with tech firms to advance clinical AI adoption
    Federal health officials, including the FDA, CMS and HHS, convened a closed-door "clinical AI demo day" to discuss how to safely expand the use of artificial intelligence in clinical settings. The…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Early-stage trial shows fecal microbiome capsules improve peanut tolerance in some participants
    An early-phase clinical study examined whether oral capsules containing fecal microbiome material could help people with peanut allergy. Six volunteers received the treatment and were later exposed…
    STAT · 16d agoPositive readoutPositive↗ source
  • Sanofi pauses phase 2 bronchiectasis trial of SAR445399 for strategic reasons
    Sanofi has halted a phase 2 study of its monoclonal antibody SAR445399 in adults with non‑cystic fibrosis bronchiectasis. The trial, which began in April, was a randomized, double‑blind, placebo‑co…
    Fierce Biotech · 16d agoNegative↗ source
  • Moderna begins early-stage trial of mRNA Ebola vaccine
    Moderna announced the launch of an early-phase clinical trial testing an mRNA vaccine designed to protect against Ebola virus. The study will enroll healthy volunteers to evaluate the vaccine's saf…
    STAT · 16d agoNeutral↗ source
  • Medicaid policy shift could alter primary therapy for children with autism
    The article notes that the main therapy used for children with autism may be affected by upcoming Medicaid policy changes. It highlights that the therapy, which is a cornerstone of treatment for ma…
    STAT · 17d agoRegulatoryNeutral↗ source
  • Eli Lilly removes Gaucher disease gene therapy trial from pipeline, citing unmet internal criteria
    Eli Lilly has announced the removal of a phase 1/2 study testing its GBA1 gene therapy for Gaucher disease type 1. The program was part of the assets acquired when the company bought Prevail Therap…
    Fierce Biotech · 17d agoNegative readoutNegative↗ source
  • Senate probes alleged quid pro quo in Trump administration's easing of kratom and tobacco rules
    Senate Finance Committee's top Democrat has opened an inquiry into recent policy changes affecting flavored vaping products and kratom, alleging the Trump administration softened regulations in exc…
    STAT · 17d agoRegulatoryNegative↗ source
  • STAT+: Federal regulators invite industry, researchers, and lobbyists to closed-door meetings on clinical AI
    Federal health officials invited tech companies and lobbyists to closed-door meetings as they seek to boost adoption of clinical AI.
    STAT · 16d agoRegulatoryNeutral↗ source
  • Call to unify MD and DO medical education pathways
    Physicians Abigail MacKenzie and Vijay Rajput argue that keeping medical education split between allopathic (MD) and osteopathic (DO) tracks is an outdated practice that adds no value to patient ca…
    STAT · 17d agoPositive↗ source
  • Schrödinger CEO Ramy Farid rethinks role of AI in drug discovery
    In a recent STAT AI Prognosis newsletter, Schrödinger chief executive Ramy Farid discussed how his perspective on artificial intelligence is evolving. He reflected on recent conversations about AI…
    STAT · 16d agoNeutral↗ source
  • AL Sydbank discloses share transactions by managers and related persons under MAR
    AL Sydbank issued a company announcement (No 41/2026) on 5 August 2026, informing the market of share transactions carried out by its managers and persons closely associated with them. The disclos…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Sun Noodle voluntarily recalls 134 packages of Sura Tanmen hot and sour noodles in Hawaii over undeclared fish allergen
    Sun Noodle of Honolulu announced a voluntary recall of its Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. The recall covers 134 packages, each 15.4 ounces, identified by lot…
    fda recalls · 17d agoCRLNegative↗ source
  • Danske Bank corrects placement of English PDF in transaction disclosure
    The bank originally posted a notice that attached both the Danish and English PDF files to the Danish version of its website. A correction has now moved the English PDF to the English version of th…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank corrects website link, moves English PDF to English page for shareholding report
    A correction notice was issued for Danske Bank A/S regarding the placement of an English PDF document on its website. The original announcement had both Danish and English PDFs attached under the…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank corrects website to place English PDF with share buyback filing
    Danske Bank issued a correction notice stating that the English version of a PDF document has been relocated on its website. The amendment moves the English PDF from the Danish page to the dedicat…
    globenewswire health · 17d agoRegulatoryNeutral↗ source