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663 stories matching this filter · ← front page

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  • Genetix, formerly Bluebird Bio, claims rapid turnaround and aims to treat 1,000 sickle-cell patients annually by 2030
    David Meek completed a distressed buyout of Bluebird Bio last year and has rebranded the company as Genetix. He says the transaction rescued the firm from the brink of bankruptcy and set it on a pa…
    STAT · 2mo agoDealPositive↗ source
  • Teen use of AI mental-health chatbots jumps 40% in a year, experts call for safety rules
    A recent study published in JAMA Pediatrics found that the proportion of adolescents turning to AI chatbots for mental-health advice rose from roughly one in eight to one in five within a single ye…
    STAT · 2mo agoRegulatoryNeutral↗ source
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  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 2mo agoApprovalPositive↗ source
  • Ipsen to acquire Swiss biotech Memo Therapeutics in up to €800 million deal for BK virus drug
    Ipsen announced it will purchase Memo Therapeutics, a Swiss biotech, in a transaction valued at up to about €800 million. The agreement provides Memo investors with €200 million upfront and potent…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Ebola and Marburg outbreaks highlight need for pathogen-agnostic diagnostics
    The authors describe a current Bundibugyo Ebola outbreak affecting the Democratic Republic of Congo and Uganda, which has resulted in more than 1,300 confirmed cases and over 375 deaths. While the…
    STAT · 2mo agoNegative↗ source
  • BridgeBio secures up to $1 billion in preferred equity as United Therapeutics invests $140 million to acquire Thymmune
    BridgeBio Pharma announced that Sixth Street Partners and HealthCare Royalty will provide up to $1 billion in preferred equity to support its upcoming product launches. The financing is structured…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Biotech Scorecard Q3 Highlights Upcoming Trial Readouts from Amylyx and Biogen
    STAT’s quarterly biotech scorecard lists fifteen events that could move biotech stocks, focusing on trial readouts and other milestones. Amylyx Pharmaceuticals reported results from its Phase 3 LU…
    STAT · 2mo agoNeutral↗ source
  • STAT+: More signs that GLP-1s may help with peripheral artery disease
    Anthropic will begin developing drugs, BridgeBio pockets a billion, and more biotech news from The Readout
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA permits Zyn nicotine pouches to be marketed as safer than cigarettes
    The U.S. Food and Drug Administration announced that Zyn's nicotine pouches can be advertised as a safer alternative to traditional cigarettes. The decision reflects the agency's view that the pouc…
    STAT · 2mo agoRegulatoryPositive↗ source
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 2mo agoApprovalPositive↗ source
  • Ipsen to buy Kartos Therapeutics for $450M, gaining Phase 3 myelofibrosis drug navtemadlin
    French pharmaceutical company Ipsen announced it will acquire California-based Kartos Therapeutics, paying $450 million upfront. The acquisition gives Ipsen control of navtemadlin, an MDM2 inhibito…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • Biotech firms raise record funds in 2026, with $2.1 bn round for Isomorphic Labs
    After a few slow years, the biotech financing landscape is showing signs of recovery, though investors remain cautious about where they place capital. A recent PharmaVoice reader poll found that 2…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Florida mandates EKGs for high-school athletes, but the new law may cause stress and cost
    Florida has become the first state to require electrocardiograms for high‑school athletes before they can participate in sports. The law is intended to screen for hidden heart conditions that could…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 2mo agoNeutral↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 2mo agoRegulatoryPositive↗ source
  • Talawar Therapeutics merges with JATT II Acquisition to list on Nasdaq as AstraZeneca reports Phase 3 success in pediatric bone disease
    Talawar Therapeutics announced a combination with blank‑check company JATT II Acquisition Corp, a deal that will place Talawar on the Nasdaq exchange. The SPAC transaction gives Talawar public‑mar…
    Endpoints · 2mo agoDealPositive↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • European regulators give second chance approval to Acadia’s Daybu for Rett syndrome
    European Medicines Agency's CHMP has reversed its earlier negative vote and now recommends marketing authorization for Acadia Pharmaceuticals' drug Daybu (trofinetide) for Rett syndrome. The posit…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Alkermes CEO targets orexin market after strong narcolepsy pill data
    Alkermes' incoming chief executive outlined a strategy to compete with larger rivals in the emerging orexin drug class. Recent mid-June trial results showed the experimental oral compound alixorex…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Precision strategies help de-risk rare disease therapy launches
    Commercializing a rare disease therapy presents a high‑risk, high‑reward scenario for biotech firms. Small patient populations, stringent regulatory requirements, and the need to sustain value beyo…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Endpoints News celebrates ten years of bootstrapped growth and a 50/50 founder partnership
    John Carroll and Arsalan Arif launched Endpoints News a decade ago with no seed funding or investors, describing themselves as completely broke. They built the news service from scratch, relying on…
    Endpoints · 2mo agoPositive↗ source
  • Federal grant delays threaten disability research and services
    Grants from the National Institute on Disability, Independent Living, and Rehabilitation Research have been postponed by several months, leaving researchers uncertain about funding. The delays are…
    STAT · 2mo agoRegulatoryNegative↗ source
  • FDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
    The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older. The 9-0 vote allows Moder…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • Ebola outbreak in Congo and Uganda surges 38% in a week, death toll exceeds 200
    The Africa CDC reported that the Ebola outbreak affecting eastern Congo and Uganda has now resulted in more than 200 deaths within its first month. Confirmed cases have risen to 894 across 32 heal…
    STAT · 2mo agoNegative↗ source