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878 stories matching this filter · ← front page

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  • FDA to discontinue pilot program aimed at preventing drug production issues
    The U.S. Food and Drug Administration announced it will end a pilot program that was created to help drug manufacturers address production problems before they arise. The initiative, which ran for…
    Endpoints · 27d agoRegulatoryNeutral↗ source
  • Chairman of Urbo Bank purchases €25,000 of bank's subordinated bonds
    Urbo bankas UAB disclosed that its Chairman of the Board, Marius Arlauskas, acquired the bank's subordinated bonds. The acquisition covered 25 bonds with a total consideration of EUR 25,000 and wa…
    globenewswire health · 27d agoRegulatoryNeutral↗ source
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  • Alm. Brand A/S discloses executive share transactions per EU regulation
    Alm. Brand A/S has issued a regulatory filing that details recent trading activity in its own shares by company executives and their related parties. The disclosure is made under Article 19 of EU…
    globenewswire health · 27d agoRegulatoryNeutral↗ source
  • Urbo Bank discloses board chair’s purchase of 25 subordinated bonds for €25,000
    Urbo Bank announced that its board chairman and administration head, Marius Arlauskas, bought 25 units of the bank’s subordinated bonds (ISIN LT0000135659). The purchase, amounting to €25,000, was…
    globenewswire health · 27d agoDealNeutral↗ source
  • FDA approves Nuvalent lung cancer drug shortly after GSK completes $10.6 billion acquisition
    The FDA announced Wednesday that it has approved a lung cancer medicine from Nuvalent, marking a key regulatory milestone for the biotech. The clearance arrived just a week after GlaxoSmithKline c…
    Endpoints · 28d agoApprovalPositive↗ source
  • Trump threatens up to 200% tariffs on generic drugs not manufactured in the United States
    President Donald Trump announced that his administration will consider imposing steep tariffs on generic medicines that are imported rather than produced in the United States. The proposed tariffs…
    Endpoints · 29d agoRegulatoryNegative↗ source
  • Mentari Therapeutics secures second $200M private placement to fund migraine program and advance reverse merger
    Mentari Therapeutics, a spin‑out focused on migraine treatments, announced it has arranged a second private‑placement financing of $200 million. The new capital will be used to advance its migrain…
    Endpoints · 28d agoDealPositive↗ source
  • Eli Lilly to spend $2.8 billion on AtaiBeckley acquisition as it ramps up Alzheimer’s prevention push
    Eli Lilly is signaling a renewed focus on neuroscience, emphasizing its ambition to tackle brain disorders. The company announced it will pay $2.8 billion upfront to acquire AtaiBeckley, a move in…
    Endpoints · 28d agoDealPositive↗ source
  • Crystalys Therapeutics raises $130M to launch gout drug in US and Europe
    San Diego‑based Crystalys Therapeutics announced a new $130 million Series B financing round. The capital will be used to advance its gout treatment, which already holds regulatory approval in Japa…
    Endpoints · 28d agoDealPositive↗ source
  • Summit Therapeutics shares two-year survival data for its experimental cancer drug ivonescimab in Western patients
    Summit Therapeutics presented new two-year overall survival results for its experimental antibody ivonescimab in Western participants of its global Phase 3 trial. The data were released alongside…
    Endpoints · 28d agoNeutral↗ source
  • Celldex halts development of mast cell antibody after Phase 2 failure in prurigo nodularis
    Celldex announced it will discontinue the clinical program for its mast cell‑targeting monoclonal antibody aimed at treating prurigo nodularis, a chronic itchy‑skin condition. The decision follows…
    Endpoints · 28d agoNegative readoutNegative↗ source
  • Biotech deal activity picks up in Q2 2026, signaling recovery after summer slump
    The biotech sector experienced a sharp decline in confidence last summer, leading to a slowdown in financing and partnership activity. New data show that in the second quarter of 2026, dealmaking…
    Endpoints · 28d agoDealPositive↗ source
  • Vertex pays second-highest M&A premium as sole bidder for Crinetics
    Vertex Pharmaceuticals emerged as the only bidder for Crinetics Pharmaceuticals, aiming to acquire the company. The bid involved a premium that ranks as the second-highest in the biopharma sector…
    Endpoints · 28d agoDealNeutral↗ source
  • Arrowhead's gene-silencing therapy shows strong results in two late-stage triglyceride trials
    Arrowhead Pharmaceuticals reported positive data from its lipid-lowering gene-silencing candidate Redemplo in two late-stage studies. The results suggest the therapy effectively reduces triglyceri…
    Endpoints · 28d agoPositive readoutPositive↗ source
  • FDA moves to reverse policies of former commissioner Marty Makary
    The Trump administration is actively rolling back decisions made under former FDA commissioner Marty Makary. As the White House weighs a new nominee for the agency, officials have begun revisiting…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • Former FDA oncology chief calls for agency restructuring after recent staff cuts
    Richard Pazdur, who led the FDA’s Oncology Center of Excellence for more than twenty years, said the agency now faces a "golden opportunity" to restructure its operations. He made the comments aft…
    Endpoints · 28d agoRegulatoryNeutral↗ source
  • Gilead and Merck to unveil detailed Phase 3 results of once‑weekly oral HIV regimen at AIDS 2026; Dimension Capital launches $800M fund
    Gilead Sciences and Merck announced that they will present detailed results from their Phase 3 trials of a once‑weekly oral HIV treatment regimen at the upcoming AIDS 2026 conference. The data wil…
    Endpoints · 29d agoNeutral↗ source
  • FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study
    The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
    Endpoints · 29d agoRegulatoryNegative↗ source
  • FDA to appoint permanent heads of CBER and CDER alongside new commissioner
    The FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…
    Endpoints · 29d agoRegulatoryNeutral↗ source
  • Agios halts development of next‑generation sickle‑cell drug tebapivat after disappointing mid‑stage trial
    Agios Therapeutics announced it will discontinue development of tebapivat, a next‑generation therapy for sickle cell disease, after the drug failed to demonstrate sufficient efficacy in a Phase 2 t…
    Endpoints · 29d agoNegative readoutNegative↗ source
  • Broad Institute partners with Boston Children’s Hospital and Jackson Lab to launch Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard announced a partnership with Boston Children’s Hospital and the Jackson Laboratory to create a Center for Therapeutic Genetics focused on rare diseases. The…
    Endpoints · 29d agoPositive↗ source
  • Novo Nordisk files lawsuit against Eli Lilly over allegedly deceptive GLP-1 dose ads
    Novo Nordisk has initiated legal action against Eli Lilly in a U.S. court, alleging that Lilly's recent advertisements misrepresent the dosing of GLP-1 obesity treatments. The company says the ads…
    Endpoints · 29d agoNegative↗ source
  • Novartis CEO says China partnerships driven by science, not market strategy
    Novartis chief executive Vas Narasimhan told reporters during the second quarter earnings call that the company’s recent agreements in China are motivated by scientific opportunities rather than a…
    Endpoints · 29d agoDealNeutral↗ source
  • A-Alpha Bio launches AI antibody data consortium with GSK, Boltz and partners
    A-Alpha Bio, a spin‑out founded by David Baker, announced the creation of a new consortium focused on sharing antibody design data. The group aims to address a shortage of high‑quality data that b…
    Endpoints · 29d agoDealPositive↗ source
  • FDA advisory panel to consider reclassifying several widely used peptides
    An FDA advisory committee is meeting this week to decide whether it will recommend reclassifying a group of popular peptide products. The discussion comes as the industry watches closely for any sh…
    Endpoints · 29d agoRegulatoryNeutral↗ source