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  • 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
  • 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
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  • 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
  • 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
  • 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
  • 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 $350M in biotech IPO, fueling rare disease drug development
    Electra Therapeutics completed a $350 million initial public offering, becoming the 21st biotechnology company to go public in 2026. The strong demand for its shares highlights continued investor a…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • GSK adds two China cancer-therapy licensing deals, keeping pace with industry partnership surge
    BioPharma Dive's new visualization series recapped recent activity, spotlighting GSK's licensing agreements in China and the market response. Since the start of 2025, GSK has signed five deals wit…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Ultragenyx prices Sanfilippo gene therapy at $4 million as it gains a second FDA approval; Bristol Myers halts Orum cancer drug
    The FDA approved Fayuvi, the first gene therapy for Sanfilippo syndrome Type A, with a list price of $3.95 million. This marks Ultragenyx's second gene‑therapy approval since August, earning sella…
    BioPharma Dive · 1mo agoApprovalNeutral↗ source
  • Sudan civil war forces cancer patients to endure hazardous journeys for treatment
    Medical missionary Tom Catena has run the Mother of Mercy hospital in the Nuba Mountains for over a decade, but the ongoing civil war has crippled Sudan’s health system. The remote facility, the la…
    STAT · 1mo agoNegative↗ source
  • BMS abandons $100 million Orum degrader-antibody conjugate after early phase-1 results
    Bristol Myers Squibb has decided to stop development of the degrader‑antibody conjugate it purchased from Orum Therapeutics for $100 million after reviewing data from a phase‑1 trial. The experime…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • Electra Therapeutics raises $350 million in oversubscribed IPO
    Electra Therapeutics, a South San Francisco biotech focused on inflammation, completed its Nasdaq IPO, selling 23.3 million shares at $15 each and generating $350 million in gross proceeds. This a…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • BMS drops Orum’s targeted degrader after Phase 1 results
    BMS announced it is ending development of ORM-6151, a degrader‑antibody conjugate acquired from Orum Therapeutics. The decision follows a Phase 1 trial in acute myeloid leukemia and myelodysplasti…
    BioSpace · 1mo agoNegative↗ source
  • Artelo’s oral cannabinoid agonist matches semaglutide weight loss in obese mice, doubles effect when combined
    Artelo Biosciences reported that its oral dual cannabinoid agonist, ART27.13, produced weight loss in diet‑induced obese mice that was comparable to the GLP‑1 receptor agonist semaglutide. In a fo…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Doctors urged to tell patients Asian glow signals health risk, not harmless quirk
    Brian Zhang, a second-year medical student at Stanford and student body president, wrote an opinion piece urging doctors to discuss the so-called "Asian glow" with patients. The facial flushing th…
    STAT · 1mo agoNeutral↗ source
  • Panel discusses how questions about health equity shape public trust in science
    Anil Oza reported that he participated in a National Academies of Science roundtable focused on population health and how research communication influences public trust. The discussion highlighted…
    STAT · 1mo agoNeutral↗ source
  • Rise in Young Men Seeking Cosmetic Surgery Driven by Social Media Influence, Surgeon Observes
    A board‑certified plastic surgeon in Boston reports that more young men are now filling her waiting room than ever before, making men the fastest‑growing group in aesthetic procedures. Procedures…
    STAT · 1mo agoNeutral↗ source
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
    fda press · 1mo agoApprovalPositive↗ source
  • Novo Nordisk signs up to $1.4 billion deal with Orbis Medicines to develop oral macrocycle cardiometabolic drugs
    Novo Nordisk announced a partnership with Danish biotech Orbis Medicines, valued at up to $1.4 billion, to co-develop oral macrocycle drugs aimed at cardiometabolic diseases. The collaboration wil…
    BioSpace · 1mo agoDealPositive↗ source
  • Roche's Lunsumio clears Phase 3 hurdle, paving way for broader label in indolent lymphoma
    Roche announced that its T cell engager Lunsumio successfully met the primary endpoints in a Phase 3 study of a slow growing blood cancer. The trial, conducted in patients with indolent lymphoma,…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Clinical trial enrollment crisis threatens billions in revenue and patient access
    Clinical trials are struggling with enrollment, with about 80% missing timelines and less than 5% of eligible adult cancer patients participating. Delays have huge financial impact; each day a pha…
    Fierce Biotech · 1mo agoNegative↗ source