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  • Medicare proposal would boost doctor pay for smoking and alcohol counseling by 19%
    A proposed change to Medicare’s physician fee schedule would increase reimbursement for doctors who provide counseling on tobacco cessation and alcohol or substance misuse. The proposal adds a 19%…
    STAT · 1mo agoRegulatoryPositive↗ source
  • San Diego biotech BlossomHill files for IPO to fund EGFR lung-cancer drug program
    BlossomHill Therapeutics, a San Diego oncology biotech focused on small‑molecule drugs, has filed an S‑1 registration statement to become a public company. The company, founded in February 2024 by…
    Fierce Biotech · 1mo agoDealPositive↗ source
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  • Canadian wildfires drive NYC asthma ER visits up 31% as heat wave intensifies haze
    Recent Canadian wildfires have produced massive smoke plumes that have drifted into the United States, degrading air quality across many cities. In New York City, emergency department visits for a…
    STAT · 1mo agoNeutral↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion, adding late-stage depression drug
    Eli Lilly announced it will acquire New York‑based biotech AtaiBeckley in a transaction valued at about $2.8 billion. The agreement sets the purchase price at $6.75 per share, a 26 % premium to At…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Merck's Lipfendra pill receives FDA approval as first oral PCSK9 cholesterol treatment
    The U.S. Food and Drug Administration approved Lipfendra, an oral medication from Merck that lowers low density lipoprotein cholesterol. The drug blocks the PCSK9 protein, making it the first pill…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • FDA approves Merck’s first oral PCSK9 inhibitor, marking a first for the drug class
    The U.S. Food and Drug Administration has granted approval to Merck for its oral PCSK9 inhibitor, the first drug of this type to receive such clearance. The approval represents a milestone because…
    STAT · 1mo agoApprovalPositive↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion
    Eli Lilly announced it will acquire AtaiBeckley, a biotech focused on psychedelic therapies for mental health, for an upfront cash payment of $2.8 billion. The purchase adds a new dimension to Lil…
    STAT · 1mo agoDealPositive↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 1mo agoApprovalPositive↗ source
  • Three biotech firms launch IPOs to challenge giants in cardiometabolic and immunology markets
    Braveheart Bio, Attovia Therapeutics and Vogenx filed for initial public offerings this week, adding to a surge of biotech listings in 2026. Braveheart is developing a therapy for hypertrophic car…
    BioSpace · 1mo agoDealNeutral↗ source
  • Amylyx to read out pivotal endocrine drug study results later this quarter
    Amylyx Pharmaceuticals will read out results later this quarter from a study of a new treatment for a rare endocrine disorder. The drug, avexitide, is being developed to prevent severe, uncontroll…
    STAT · 1mo agoNeutral↗ source
  • CMS proposes new payment framework for clinical software and AI to link reimbursement with patient outcomes
    The Centers for Medicare & Medicaid Services (CMS) has released proposed rules for 2027 that would create a standardized payment structure for clinical software and artificial intelligence tools. T…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Podcast highlights prediction markets entering biotech and Biogen Alzheimer's drug controversy
    The Readout LOUD episode released on July 16, 2026 features hosts Elaine Chen, Adam Feuerstein and Allison DeAngelis. The trio discuss trends shaping biotech, from new obesity treatments to evolvin…
    STAT · 1mo agoNeutral↗ source
  • Kalshi launches prediction markets for clinical trial results and FDA approvals
    Kalshi, a major prediction market exchange, announced it will begin offering markets that let participants bet on the outcomes of clinical trials and on whether drugs will receive FDA approval. Th…
    STAT · 1mo agoPositive↗ source
  • Venom’s hidden potential fuels next wave of peptide medicines beyond GLP-1 weight-loss drugs
    Steve Midway, an associate professor at LSU, argues that many powerful medicines already exist in the venoms of feared creatures, noting that venom contributed to the development of GLP-1 based wei…
    STAT · 1mo agoPositive↗ source
  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 1mo agoPositive↗ source
  • Defense Secretary proposes annual testosterone screening for service members, sparking mixed expert reaction
    U.S. Defense Secretary Pete Hegseth announced that service members will have testosterone deficiency testing added to their annual physical exams. The plan targets war-fighters aged 30 and older, w…
    STAT · 1mo agoNeutral↗ source
  • Kelun-Biotech reports first-line success of Merck-partnered ADC sacituzumab tirumotecan in China
    Kelun-Biotech announced that its antibody‑drug conjugate sacituzumab tirumotecan, developed in partnership with Merck, achieved its primary efficacy endpoints when used as a first‑line therapy in a…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Celcuity receives FDA approval for Revtorpyk, a breast cancer therapy, but shares drop nearly 20% amid launch delay concerns
    Celcuity announced that the U.S. Food and Drug Administration cleared its breast cancer drug Revtorpyk for use in combination with hormone therapy and Pfizer's Ibrance in patients with ER-positive,…
    BioPharma Dive · 1mo agoApprovalNegative↗ source
  • Merck's sac-TMT shows promise in Chinese Phase 3 lung cancer trial, may replace chemo
    Merck and its Chinese partner Kelun-Biotech reported that the antibody-drug conjugate sac-TMT slowed disease progression better than a standard chemotherapy regimen in a Phase 3 trial conducted in…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Celcuity’s breast cancer therapy gets FDA approval as new CBER chief outlines biotech priorities
    Celcuity announced that its first breast cancer drug has been approved by the U.S. Food and Drug Administration, marking the company’s initial market entry in oncology. The announcement coincided…
    STAT · 1mo agoApprovalPositive↗ source
  • Medicare proposes ban on vendor-provided remote patient monitoring services
    Medicare regulators have proposed a rule that would prohibit vendors from delivering remote patient monitoring services on behalf of physicians, marking a significant policy shift. Remote patient…
    STAT · 1mo agoRegulatoryNegative↗ source
  • AdvanCell secures $315M Series D to advance lead-based prostate cancer therapy
    AdvanCell announced a $315 million Series D financing round aimed at supporting development of its lead-based prostate cancer agent and expanding U.S. manufacturing capacity for the radioactive tre…
    Endpoints · 1mo agoDealPositive↗ source