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  • Congress pushes back on White House plan to place political appointees on NIH grant reviews
    Members of Congress have voiced strong opposition after a leak revealed a White House proposal to create a commission of political appointees that would review every NIH grant. The idea reportedly…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Global Mix Inc. recalls Niwali Tejocote supplements after FDA finds toxic yellow oleander content
    Global Mix Inc., based in Middle Village, New York, announced a recall of its Niwali Tejocote Capsules and Pieces, both marketed as herbal dietary supplements. The FDA’s analysis indicated the pro…
    fda recalls · 1mo agoRegulatoryNegative↗ source
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  • Pentagon defends labeling WuXi AppTec as Chinese military firm, warning of contract limits
    The U.S. Department of Defense is standing by its recent decision to place WuXi AppTec on a list of companies tied to the Chinese military. The designation could bar the contract manufacturing fir…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA provides minimal comment on Grail cancer test before advisory committee meeting
    The FDA typically releases briefing documents that give a clear stance on a drug or diagnostic's safety and efficacy before its advisory committee convenes. In the upcoming meeting concerning Grai…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • NIH launches Linked Discoveries tool on PubMed to streamline finding related biomedical papers
    The National Institutes of Health’s National Library of Medicine has released a pilot version of a new tool called Linked Discoveries on PubMed. The feature adds a button to a paper’s page that op…
    Fierce Biotech · 1mo agoPositive↗ source
  • Pfizer and Eli Lilly sign 'most favored nation' pricing deals to share foreign price hikes with US government
    Pfizer and Eli Lilly have entered into “most favored nation” agreements with the Trump administration, according to a recent report. The deals require the two companies to remit a portion of the a…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA approves IntraBio's Aqneursa for rare ataxia-telangiectasia disorder
    FDA has granted approval for Aqneursa, a therapy developed by privately held biotech IntraBio, to treat ataxia-telangiectasia, a rare genetic disorder. The decision expands treatment options for pa…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Telix to acquire German radioisotope maker ITM in deal valued up to $2.35 billion
    Telix Pharmaceuticals announced it will purchase ITM Isotope Technologies Munich SE, a German producer of medical radioisotopes, for an upfront payment of $1.65 billion. The transaction could rise…
    Endpoints · 1mo agoDealNeutral↗ source
  • ADARx aims for $318 million IPO as TRexBio and Retension also file
    ADARx Pharmaceuticals, a siRNA biotech currently in Phase 3 trials, announced plans to raise roughly $318 million through an initial public offering. The company is joining other biotech firms suc…
    Endpoints · 1mo agoDealNeutral↗ source
  • Alkermes' orexin agonist ALKS 7290 shows promise in early-stage ADHD trial
    Alkermes reported results from a Phase 1 study of its orexin agonist ALKS 7290, a drug class previously explored for rare sleep disorders. The trial enrolled adults with moderate to severe ADHD, a…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Novo Nordisk outlines new obesity and consumer-focused strategy, targets five multi-blockbusters by 2030
    Novo Nordisk used its capital markets day to reassure investors by unveiling a plan to broaden its pipeline beyond diabetes and obesity. The company said it will aim to launch at least five multi-b…
    STAT · 1mo agoNeutral↗ source
  • STAT launches first trust-in-science reporter to explore declining public confidence in health research
    Alex Hogan, senior multimedia producer at STAT, hosts the weekly video series STATus Report and recently aired an episode titled “Why is trust in science important?”. The episode notes that public…
    STAT · 1mo agoNeutral↗ source
  • TRex Bio and Retension Pharma announce plans for IPOs, outlining biotech pipeline funding
    Biotech companies Retension Pharmaceuticals and TRex Bio have filed with the SEC indicating they intend to go public this year, adding to the current wave of biotech IPOs. TRex Bio said it will us…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Regulators call for unified AI guidelines in drug development at RAPS Convergence 2026
    Regulators and industry experts gathered at RAPS Convergence 2026 in Charlotte, NC to discuss the growing role of artificial intelligence in drug development. The panel highlighted that differing…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA staff flag no major concerns for Grail's multi-cancer test ahead of advisory committee
    FDA staff have completed a review of Grail's multi-cancer early detection test and reported no major concerns. The assessment comes as the test approaches a scheduled advisory committee meeting, w…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Novo outlines diversification strategy with new pipeline assets and bolt-on deals
    Novo Pharmaceuticals' chief executive Maziar Mike Doustdar used the company's recent capital-markets day in London to lay out a diversification plan. He said the rebranded firm will focus on expand…
    Endpoints · 1mo agoDealPositive↗ source
  • Cue Biopharma's chronic hives drug clears Phase 2 trial, first immunology data after cancer pivot
    Cue Biopharma announced that its candidate for chronic spontaneous urticaria successfully completed a Phase 2 trial in China. The trial marks the company's first clinical data since it shifted its…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Cue Biopharma's CUE-221 meets primary endpoint in phase 2 CSU trial, eyes phase 2b/3
    Cue Biopharma reported that its chronic spontaneous urticaria (CSU) candidate CUE-221 achieved the primary endpoint in a midstage study conducted in China. The trial enrolled 145 patients who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • FDA to replace animal testing terms with broader nonclinical language in regulations
    The U.S. Food and Drug Administration announced it will revise its regulations to replace references to animal testing with broader terms such as "nonclinical tests" and "nonclinical studies". The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Addiction clinics see rising cases of kratom and 7-OH withdrawal
    Addiction clinics are seeing a surge in patients dependent on potent kratom and 7-OH products.
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Iambic Therapeutics launches next-gen Enchant AI model and inks R&D partnership with AbbVie
    Iambic Therapeutics, a San Diego‑based biotech founded in 2019, announced the release of the next generation of its Enchant artificial‑intelligence model. The updated model is intended to enhance…
    Endpoints · 1mo agoDealPositive↗ source
  • Singapore’s Health Sciences Authority expands regulatory partnerships across Africa, Asia and Europe
    Singapore’s Health Sciences Authority (HSA) announced that it is broadening its regulatory reliance and cooperation framework. The agency is establishing new alliances with regulatory bodies in se…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Experts urge ClinicalTrials.gov to add pregnancy and lactation checkbox to aid trial enrollment
    Patients who are pregnant or nursing often struggle to locate clinical trials that accept them, and clinicians face the same obstacle when advising participants. ClinicalTrials.gov lists more than…
    STAT · 1mo agoPositive↗ source
  • Trump calls for new vaccine while echoing vaccine misinformation
    A recent STAT newsletter reported that President Donald Trump announced he will demand a new vaccine, echoing long-standing vaccine misinformation. The claim was made a day after health secretary R…
    STAT · 1mo agoNegative↗ source
  • STAT launches trust-in-science reporter to explore public skepticism of modern medicine
    STAT has added a new reporter, Nicholas Florko, to cover trust in science and examine why many people doubt modern medicine. Florko, who also deals with personal health issues such as high cholest…
    STAT · 1mo agoNeutral↗ source