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177 stories matching this filter · ← front page

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  • AstraZeneca acquires Omniose to boost conjugate vaccine platform as FDA flags vision-loss risk for GLP-1 drugs
    AstraZeneca announced it has acquired vaccine startup Omniose, though the financial terms were not disclosed. The purchase gives AstraZeneca access to Omniose's bioconjugation technology, a method…
    BioPharma Dive · 1d agoDealNeutral↗ source
  • Dual targeting of GPCRs and mutated Gαq/11 shows promise for uveal melanoma
    Researchers at Thomas Jefferson University reported a new strategy to disrupt signaling in uveal melanoma, a rare eye cancer. The study found that simultaneously inhibiting the G protein-coupled r…
    Fierce Biotech · 23h agoPositive readoutPositive↗ source
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Nephrology764
  • Oura to buy AI virtual care firm Counsel Health for $625 million, expanding in-app health services
    Oura, known for its smart ring and health tracking, announced it will acquire Counsel Health, an AI-driven virtual primary-care provider, for $625 million in cash. The acquisition is slated to clo…
    Fierce Biotech · 2d agoDealPositive↗ source
  • FDA requires GLP-1 drug labels to include warning about rare eye disease
    The FDA has issued a directive to manufacturers of GLP-1 therapies, instructing them to revise product labeling. The label change must highlight an increased risk of a rare ocular condition that c…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 3d ago↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 6d agoApprovalPositive↗ source
  • New treatments for preeclampsia move closer to patients
    Emily Chaddock’s experience highlights the danger of severe preeclampsia, a pregnancy complication that can threaten both mother and baby. At 27 weeks she developed the condition, leading to a rapi…
    Endpoints · 6d agoPositive↗ source
  • Cloudbreak Pharma’s Phase 3 Eye Drop Shows Significant Benefit in Pterygium Trial
    Cloudbreak Pharma reported that its phase 3 trial of CBT-001, a multi‑kinase inhibitor eye drop for pterygium, met both co‑primary endpoints. The study compared two doses of CBT-001 given twice da…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • Minghui licenses sub-q TED drug to Japan's ASKA in up to $440 million deal
    Minghui Pharmaceutical of China has signed a licensing agreement with Japan's ASKA Pharmaceutical, granting exclusive rights to develop and sell its late‑stage thyroid eye disease (TED) candidate i…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Minghui Pharma sells Japanese rights to its Phase 3 thyroid eye disease drug for $110 million upfront
    Minghui Pharmaceutical, a Shanghai‑based biotech, has agreed to transfer the Japanese commercial rights for its late‑stage thyroid eye disease candidate to a specialty pharmaceutical company. The…
    Endpoints · 8d agoDealPositive↗ source
  • Spyre Therapeutics reports SPY072 fails psoriatic arthritis trial as Ideaya halts eye cancer study
    Spyre Therapeutics announced that its long‑acting anti‑TL1A candidate, SPY072, did not meet the primary endpoints in a psoriatic arthritis trial. The result adds to recent setbacks for Spyre in ot…
    Endpoints · 8d agoNegative readoutNegative↗ source
  • nPhase secures $30M Series D to grow AI-driven clinical data platform
    CRO nPhase announced it has closed a $30 million Series D financing round. The capital will be directed toward expanding its AI-native clinical data platform that debuted in September, which aims t…
    Fierce Biotech · 8d agoDealPositive↗ source
  • AstraZeneca outlines restructuring as earnings show cost cuts, while Alnylam slides and Regeneron posts record quarter
    AstraZeneca said it will redeploy resources through a new restructuring program aimed at cutting costs while staying on track to hit its long‑term revenue goal of $80 billion by 2030. The company h…
    BioPharma Dive · 10d agoEarningsNeutral↗ source
  • Flagship Pioneering merges three biotech startups to launch AI-driven drugmaker Etcelera
    Flagship Pioneering announced the creation of Etcelera Therapeutics by merging three of its portfolio companies - Etiome, Cellarity and Empress Therapeutics. The new venture will combine artificia…
    BioPharma Dive · 14d agoDealPositive↗ source
  • FDA approves Stada's Lucentis biosimilar; Lilly claims its triple-G candidate outperforms Ozempic in diabetes
    The U.S. Food and Drug Administration has granted approval for Stada's biosimilar version of Lucentis, expanding treatment options for eye diseases. Lilly announced that its experimental "triple‑G…
    raps · 14d agoApprovalPositive↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 14d agoNeutral↗ source
  • FDA proposes new rare disease framework to accelerate therapy development
    During a public hearing, FDA officials outlined a newly proposed rare disease framework aimed at creating a lasting regulatory scheme. The initiative seeks to speed the development of safe and eff…
    Fierce Biotech · 15d agoRegulatoryPositive↗ source
  • Biogen CEO says early-stage R&D now a priority after record five INDs this year
    Biogen's chief executive Chris Viehbacher told analysts that the company has shifted its strategy toward early-stage research and development. He highlighted that Biogen has filed five investigati…
    Fierce Biotech · 15d agoPositive↗ source
  • Leak of Moderna-Merck cancer vaccine phase 3 data sparks drama at ESMO 2026 conference
    The European Society for Medical Oncology (ESMO) meeting this year was marked by an unexpected leak of phase 3 results for a cancer vaccine being developed by Moderna and Merck. The data appeared t…
    Fierce Biotech · 16d agoNeutral↗ source
  • Anthropic IPO filing reveals plans to build a drug discovery lab and pursue AI-driven therapeutics, noting scientific and regulatory hurdles
    Anthropic, known for its Claude AI platform, disclosed in its S-1 that it intends to expand into life-science research, including establishing its own molecular biology laboratory. The company aim…
    Fierce Biotech · 17d agoNeutral↗ source
  • Corxel to go public via $300 million SPAC merger, advancing GLP-1 pill CX11 and amylin candidate
    Corxel Pharmaceuticals announced it will become a public company by merging with the SPAC Amanat Acquisition Corp., accompanied by a $300 million private investment. The transaction will fund the…
    BioPharma Dive · 17d agoDealPositive↗ source
  • Aspen Neuroscience and Bambusa Therapeutics each aim for $135 million IPOs
    Aspen Neuroscience announced plans to raise about $135 million through an initial public offering, proposing to sell roughly 9.38 million shares. Bambusa Therapeutics also filed for an IPO targeti…
    Endpoints · 17d agoDealNeutral↗ source
  • Roivant's brepocitinib shows strong Phase 3 results, paving way for uveitis indication
    Roivant subsidiary Priovant Therapeutics announced positive Phase 3 data for its anti‑inflammatory drug brepocitinib in patients with non‑infectious uveitis, an eye disease that can cause blindness…
    BioPharma Dive · 22d agoRegulatoryPositive↗ source
  • Alcon buys Neurotech for $550 million upfront
    Alcon, the Swiss eye‑care company, announced it has completed the acquisition of Neurotech Pharmaceuticals. The transaction includes an upfront cash payment of $550 million, with the possibility o…
    Endpoints · 22d agoDealNeutral↗ source
  • Astellas teams up with Boston miniprotein startup to explore AI-designed tiny proteins
    Astellas Pharma announced a partnership with a Boston-based startup that specializes in miniproteins, small engineered proteins that can serve as therapeutic agents. The startup leverages artifici…
    Endpoints · 23d agoDealPositive↗ source