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  • 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
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  • 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
  • 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
  • Republican Iowa governor candidate teams with RFK Jr. as poll lag persists
    Zach Lahn, a farmer and Republican candidate, is running for Iowa governor and currently trails the Democratic opponent in recent polls. Lahn has highlighted his partnership with health secretary…
    STAT · 1mo agoNeutral↗ source
  • Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    BioSpace · 1mo ago↗ source
  • Telix to acquire ITM Isotope Technologies in $1.65 billion radiopharma merger
    ITM Isotope Technologies Munich SE and Telix Pharmaceuticals announced a merger that will combine two leading radiopharmaceutical developers. The transaction is valued at a minimum of $1.65 billio…
    STAT · 1mo agoDealNeutral↗ source
  • Jehovah's Witnesses ease ban, permitting blood-derived products while still forbidding whole-blood transfusions
    The religious group announced a revision to its long-standing medical policy, now allowing members to receive products derived from donated blood. The new guidance says individuals may accept plas…
    STAT · 1mo agoNeutral↗ source
  • Novartis faces another setback while Novo drops Nordisk partnership
    The latest edition of Endpoints Weekly notes that Novartis experienced another failure, though the newsletter does not provide details about the product or trial. It also reports that Novo Nordisk…
    Endpoints · 1mo agoNegative↗ source
  • Ultragenyx receives FDA approval for Fayuvi, first therapy for Sanfilippo syndrome type A, priced at $3.95 M
    The FDA has approved Ultragenyx's gene therapy rebisufligene etisparvovec, to be sold under the brand name Fayuvi, for the treatment of Sanfilippo syndrome type A, an ultra-rare progressive neurolo…
    BioSpace · 1mo agoApprovalPositive↗ source
  • FDA approves Eli Lilly's oral SERD Inluriyo combo for second-line metastatic breast cancer
    The FDA has given approval to a new combination therapy from Eli Lilly that includes its oral selective estrogen receptor degrader, Inluriyo, for patients with metastatic breast cancer who have pro…
    Endpoints · 1mo agoApprovalPositive↗ source
  • China unveils five-year plan to grow biotech sector from $3M to $522B by 2030
    China's Ministry of Industry and Information Technology released a new five-year biotech plan that sets out ambitious growth targets for the sector. The plan aims to expand the industry from rough…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • EU regulator backs Novo's hemophilia A preventive therapy and recommends seven additional drugs
    The European Medicines Agency's human medicines committee issued a positive opinion on Novo's preventive treatment for hemophilia A, indicating it meets the agency's standards for further developme…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Electra Therapeutics raises $350M in IPO to fund pivotal immune-disease antibody development
    Electra Therapeutics announced an initial public offering that raised $350 million, exceeding its earlier target. The IPO consisted of 23.3 million shares sold at $15 per share, and underwriters w…
    BioSpace · 1mo agoDealPositive↗ source
  • Xenon shares plunge 23% after voluntary hold on psychiatry trials, despite filing NDA for epilepsy drug
    Xenon Pharmaceuticals announced that its lead asset azetukalner (AZK) has been submitted to the FDA as a new drug application for focal onset seizures. At the same time, the company disclosed a vo…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Roche opens new research center in Boston, expanding its local presence
    Roche announced the opening of a new research facility in Boston, adding to its existing operations in the city. The center will focus on early-stage drug discovery and will house several hundred…
    STAT · 1mo agoPositive↗ source
  • Electra Therapeutics raises $350 million in Nasdaq IPO to fund commercial expansion
    Electra Therapeutics announced that it priced its initial public offering on the Nasdaq at $350 million, becoming the 21st biotech to go public in 2026. The Bay Area‑based company said the capital…
    Endpoints · 1mo agoDealPositive↗ source
  • All 50 states, DC, and Puerto Rico join new Medicaid most-favored-nation drug pricing model, Trump says
    President Donald Trump announced that every U.S. state, the District of Columbia and Puerto Rico will take part in a new Medicaid drug‑pricing framework. The model requires pharmaceutical manufact…
    Endpoints · 1mo agoRegulatoryNeutral↗ source