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2,160 stories matching this filter · ← front page

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  • FDA advisory panel backs compounding of unapproved peptides BPC-157 and KPV
    An FDA advisory panel voted narrowly to recommend that compounding pharmacies be permitted to produce the unapproved peptides BPC-157 and KPV. The recommendation is seen as a victory for supporter…
    STAT · 22d agoRegulatoryPositive↗ source
  • 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 · 22d agoRegulatoryNeutral↗ source
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  • U.S. health officials probe new cyclospora outbreak affecting 72 people
    Federal health agencies are looking into a recent cluster of illnesses caused by the parasite cyclospora, which leads to diarrhea. As of the latest report, 72 individuals have been identified with…
    STAT · 22d agoRegulatoryNeutral↗ source
  • Bipartisan Senate Bill Aims to Create Office of Men’s Health
    The U.S. Senate will introduce the Men’s Health Act on Thursday, led by Rep. Ruben Gallego (D‑Ariz.) with Rep. Roger Marshall (R‑Kan.) as a co‑sponsor. The legislation mirrors a similar bipartisan…
    STAT · 23d agoRegulatoryPositive↗ source
  • Senate health panel pushes CDC nominee vote to next week
    The Senate health committee announced that the vote on Erica Schwartz's nomination to lead the Centers for Disease Control and Prevention has been delayed until next week because too few senators w…
    STAT · 22d 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 · 23d agoRegulatoryNeutral↗ source
  • 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 · 23d agoRegulatoryNeutral↗ source
  • Veterans Still Await Reinstatement After Trump's Promise to Restore Service for Covid Vaccine Refusers
    When the COVID-19 vaccine became available in 2020, President Trump said he would offer a path to redemption for service members who declined the shots. A year later, four veterans who sought rein…
    STAT · 23d agoNegative↗ 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 · 23d 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 · 23d agoApprovalPositive↗ source
  • Congo Ebola outbreak kills 999, fastest recorded spread with no approved vaccine
    Official data from Congo’s Ministry of Health shows that 2,473 Ebola cases have been recorded and 999 deaths have occurred, with 737 patients still in isolation. The outbreak, declared on May 15,…
    STAT · 23d agoNegative↗ source
  • AstraZeneca’s rare disease drug Wainua fails Phase 3, narrowing path to $80 billion sales goal
    AstraZeneca announced that its rare disease therapy Wainua did not meet its primary endpoints in a Phase 3 trial, ending plans to broaden the drug’s label for transthyretin amyloidosis cardiomyopat…
    BioSpace · 24d agoNegative readoutNegative↗ 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 · 24d agoRegulatoryNegative↗ source
  • Repligen to acquire BioLife Solutions for $1.5 billion, boosting its role in cell therapy preservation
    Repligen announced a $1.5 billion acquisition of BioLife Solutions, a company whose CryoStor media is used to preserve cell therapies during storage and transport. BioLife’s products are employed…
    BioSpace · 24d agoDealPositive↗ source
  • Eli Lilly’s $3.8 billion acquisition of AtaiBeckley signals strong backing for psychedelic therapeutics
    Novartis and Roche kicked off the second‑quarter earnings season, with other majors such as AstraZeneca, GSK and Biogen slated to follow. The earnings wave highlights continued revenue growth acros…
    BioSpace · 24d agoDealPositive↗ source
  • FDA approves Merck’s oral PCSK9 inhibitor Lipfendra, but cardiologists question its immediate impact
    The FDA has granted approval to enlicitide, marketed by Merck as Lipfendra, marking the first oral PCSK9 inhibitor for lowering blood cholesterol. The drug arrives as new clinical guidelines encou…
    STAT · 24d agoApprovalNeutral↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 23d agoRegulatoryPositive↗ source
  • NIH joins Trump’s $5B AI Genesis Mission to boost biomedical research
    The U.S. Department of Health and Human Services announced that the National Institutes of Health will take part in the President’s Genesis Mission, a $5 billion AI-driven effort. The initiative a…
    Fierce Biotech · 23d agoRegulatoryPositive↗ source
  • Arrowhead reports Phase 3 data showing potentially best-in-class triglyceride reduction, eyes FDA filing
    Arrowhead Pharmaceuticals announced topline results from two late-stage Phase 3 trials (SHASTA-3 and SHASTA-4) of its siRNA drug plozasiran in patients with severe hypertriglyceridemia (sHTG). Th…
    BioSpace · 24d agoPositive readoutPositive↗ 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 · 24d 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 · 24d agoDealPositive↗ source
  • Trump announces steep tariffs on imported generic drugs, starting 100% in 2028 and rising to 200% in 2029
    President Donald Trump disclosed a plan to levy heavy tariffs on generic medicines that are imported into the United States. The tariff would be set at 100 percent beginning in August 2028 and woul…
    STAT · 24d agoRegulatoryNegative↗ source
  • Congressional panel warns US rare-disease lead is eroding and calls for supportive policies
    A Congressional advisory panel has urged the U.S. government to adopt policies that would help rare disease drug development, including a finalized FDA platform designation and the use of novel tri…
    BioSpace · 24d agoNegative↗ 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 · 24d 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 · 24d agoNeutral↗ source