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  • Zealand Pharma appoints former Lilly executive as US marketing head
    Silvia Luque announced on LinkedIn that she will lead US marketing for Zealand Pharma. The appointment follows a 13-year tenure at Eli Lilly, where she held several roles in the company's obesity f…
    Endpoints · 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
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  • 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
  • Merck secures US approval for the first oral PCSK9 cholesterol-lowering pill, edging out AstraZeneca
    Merck has received the United States regulatory clearance for an oral PCSK9 inhibitor, marking the first time a pill of this class has been approved for cholesterol management. The approval comes…
    Endpoints · 1mo agoApprovalPositive↗ 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
  • US drug shortages climb for third consecutive quarter, many rely on single suppliers
    The latest data show that the count of medicines in shortage across the United States increased again in the most recent quarter, marking the third straight period of growth. Analysts note that ne…
    Endpoints · 1mo agoNegative↗ source
  • Mirador Therapeutics announces partnership to acquire Kira drug, positioning it against Tavneos
    Mirador Therapeutics, a San Diego‑based biotech focused on immune diseases and backed by more than $650 million in venture capital, has disclosed a new element of its development pipeline. The com…
    Endpoints · 1mo agoDealPositive↗ source
  • Veradermics' experimental hair loss pill shows promising results in women
    Veradermics reported positive Phase 2 data for its oral minoxidil formulation VDPHL01 in women with mild-to-moderate pattern hair loss. The study enrolled 28 participants who took the drug once or…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Alzheimer researcher Betty Tijms urges broader view beyond amyloid and tau
    Betty Tijms, head of science at the Alzheimer Center Amsterdam, says it is time to stop treating Alzheimer’s as a single disease. For more than a century, research has focused on two proteins, amy…
    Endpoints · 1mo agoNeutral↗ source
  • Sanofi sues Pfizer and Moderna over alleged infringement of mRNA delivery patents
    Sanofi has filed a lawsuit against Pfizer and Moderna, accusing the two companies of violating its patents covering lipid nanoparticle technology used to deliver mRNA in vaccines. The French drugm…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Eli Lilly to acquire AtaiBeckley for $2.8 billion, signaling deeper bet on psychedelics
    Eli Lilly announced on Thursday that it will acquire psychedelic drug developer AtaiBeckley. The purchase price is set at $2.8 billion paid upfront. The sizable upfront payment highlights Lilly's…
    Endpoints · 1mo agoDealPositive↗ 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
  • EMA issues guidance to curb microbial contamination in non-sterile medicines; MHRA reports record drug approvals
    The European Medicines Agency has issued new guidance that outlines technical and organisational measures to reduce the risk of microbial contamination in non-sterile pharmaceutical products. The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps toward AI oversight in healthcare
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines this year than in t…
    raps · 1mo agoRegulatoryNeutral↗ 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
  • Reporter attends AHA Leadership Summit in Denver to gauge hospital executives' priorities
    The author attended the American Hospital Association’s Leadership Summit in downtown Denver earlier this week. While there, the author handed out ice cream recommendations to attendees. The prim…
    Endpoints · 1mo agoNeutral↗ 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
  • FDA acting chief says two journal articles by former commissioner do not represent agency policy
    Acting FDA Commissioner Kyle Diamantas announced that the agency is reversing its earlier position regarding two medical‑journal articles authored by former commissioner Marty Makary. The FDA now…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Johnson & Johnson to spend up to $750 million restructuring pharma manufacturing and closing plants
    Johnson & Johnson announced it will incur up to $750 million as it reshapes its pharmaceutical manufacturing network. The plan involves exiting certain factories and consolidating production, aimi…
    Endpoints · 1mo agoNeutral↗ 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
  • J&J reports 18,000 new prescriptions for Icotyde in first full quarter
    Johnson & Johnson gave an update on the launch of its plaque-psoriasis drug Icotyde. The company said that in its first full quarter on the market, Icotyde generated about 18,000 new prescriptions…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • J&J shares fall 3% as oncology sales miss forecasts, while AstraZeneca invests $600M in lung cancer drug
    Johnson & Johnson’s stock slipped about 3% on Wednesday even though the company raised its full‑year sales outlook. In its latest quarterly earnings release the firm said revenue in its innovative…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 1mo agoDealPositive↗ source
  • Braveheart Bio seeks Nasdaq listing to finance Phase 3 trial of Hengrui rival cardio drug
    Braveheart Bio announced it has filed for an initial public offering on the Nasdaq exchange. The company says the capital raised will be used to fund a Phase 3 study of its cardiovascular candidate…
    Endpoints · 1mo agoNeutral↗ source