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2,146 stories matching this filter · ← front page

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  • FDA updates instructions for NOxBOXi nitric oxide delivery system after leak risk identified
    The FDA has issued a correction for the NOxBOXi nitric oxide delivery system with the NOxMixer module after discovering that the device can leak oxygen during inhaled nitric oxide therapy. The age…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • China biotech policy debate moves to Washington for live discussion
    Endpoints News brought its ongoing China biotech debate to the nation’s capital, arranging a live session with officials shaping upcoming regulations. The event featured interviews with several po…
    Endpoints · 1mo agoNeutral↗ source
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  • 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
  • North Immunology to go public via reverse merger with Aethlon, targeting eczema market
    North Immunology, an early-stage biotech developing a dual-acting antibody for eczema, announced plans to become a public company through a reverse merger with Aethlon Medical. The transaction wil…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Orbis Medicines signs up to $1.4 billion partnership with Novo to develop macrocycle drugs for cardiometabolic disease
    Orbis Medicines, which is backed by Eli Lilly, announced a new collaboration with Novo focused on drug discovery. The agreement, valued at up to $1.4 billion, will target the creation of macrocycl…
    Endpoints · 1mo agoDealNeutral↗ source
  • Novo and Orbis strike up to $1.4 billion partnership to develop oral peptide macrocycles for cardiometabolic disease
    Novo Pharmaceuticals has entered a partnership with fellow Danish firm Orbis Medicines that could be worth as much as $1.4 billion. The agreement includes upfront payments, downstream payouts and r…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Lisata acquires Marea Therapeutics, securing $225M financing to advance two mid-stage drugs
    Lisata Therapeutics completed a stock-for-stock acquisition of biotech startup Marea Therapeutics. The transaction includes a $225 million financing round led by existing backers such as Forbion,…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA confronts surge of Chinese biotech firms as they become key industry players
    The FDA is currently assessing how to handle the rapid growth of biotech companies from China, which have moved from being economic competitors to important contributors in the pharmaceutical lands…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • UK parliamentary committees demand probe into cost of US-UK pharma trade deal
    Six UK parliamentary committees have written to the relevant watchdog asking for an investigation into the cost of the United Kingdom's pharmaceutical trade agreement with the United States. The c…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Michael J. Fox Foundation backs Ariadne Bio's non-hallucinogenic psychedelic for Parkinson's
    Ariadne Bio, a new biotech focused on Parkinson's disease, has received backing from the Michael J. Fox Foundation. The partnership centers on a non‑hallucinogenic psychedelic candidate that the fo…
    Endpoints · 1mo agoDealPositive↗ source
  • Roche partners with Dualitas Therapeutics in up to $1 billion deal to screen bispecific antibodies for immune diseases
    Roche has committed $36.5 million up front to biotechnology startup Dualitas Therapeutics under a research partnership that could total up to $1 billion in milestone payments and royalties. The agr…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • EU officials outline major pharmaceutical legislative reforms at RAPS Convergence 2026
    At RAPS Convergence 2026 in Charlotte, North Carolina, officials from the European Commission and the European Medicines Agency presented a set of reforms aimed at overhauling the European Union’s…
    raps · 1mo agoRegulatoryPositive↗ source
  • Bristol Myers ends $100M Phase 1 cancer ADC program
    Bristol Myers Squibb announced it has discontinued development of its Phase 1 antibody-drug conjugate candidate BMS-986497/ORM-6151. The decision follows a review of early clinical data, leading t…
    Endpoints · 1mo agoNegative↗ source
  • CMS offers Medicare pricing program exemptions to drugmakers who add Medicaid rebates
    The Centers for Medicare & Medicaid Services (CMS) has announced that drug manufacturers can be exempted from two Medicare pricing demonstration programs. The exemption is conditional on the compan…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Cellares signs first Asian manufacturing deal with Taiwan's GenomeFrontier Therapeutics for CAR-T production
    Cellares announced a new partnership with Taiwanese biotech GenomeFrontier Therapeutics, marking the manufacturer’s first collaboration in Asia. The agreement will see Cellares evaluate and potenti…
    Endpoints · 1mo agoDealNeutral↗ source
  • Senate schedules hearing for FDA nominee as Novo teams with Anthropic on AI drug development
    The Senate has announced a hearing to consider the nominee for the next FDA commissioner, signaling a forthcoming review of the agency's leadership. In parallel, biotech firm Novo has entered a pa…
    raps · 1mo agoRegulatoryNeutral↗ source
  • CMS launches 10-year ACCESS health-tech pilot for Medicare
    CMS recently held an event to commemorate the summer launch of the ACCESS model, a decade-long pilot aimed at integrating health-technology solutions into Medicare. The program will test new digit…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Endpoints 11 reveals 2026’s most promising biotech startups at Boston gala
    The Endpoints editorial team announced the Endpoints 11 list, highlighting the most exciting biotech startups of 2026. The selection process involved months of research, interviews with executives,…
    Endpoints · 1mo agoNeutral↗ source
  • MHRA AI Commission Issues 44 Recommendations for Future UK Regulatory Framework
    A commission established by the Medicines and Healthcare products Regulatory Agency has released its findings. The group presented 44 recommendations aimed at shaping the United Kingdom’s regulato…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Former FDA chief Califf calls for regulatory overhaul and predicts AI assistants in future oversight
    Robert Califf, who served as FDA commissioner, reflected on his early experience as a medical student in the 1970s working with a pioneering patient database that tracked cardiovascular procedures…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Bavarian Nordic appoints former Sanofi, AstraZeneca and Pfizer executive Tarja Stenvall as CEO
    Bavarian Nordic announced that Tarja Stenvall will become its president and chief executive, succeeding Paul Chaplin. Stenvall brings decades of experience from senior roles at Sanofi, AstraZeneca…
    Endpoints · 1mo agoNeutral↗ source
  • FDA officials stress administration priorities in draft PDUFA VIII commitment letter
    At a public meeting on Wednesday, FDA officials presented the proposed commitment letter for the upcoming PDUFA VIII program. The letter reiterates the administration's priorities, reflecting the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • General Catalyst outlines tech collaborations with Summa Health after hospital acquisition
    General Catalyst, a venture capital firm, is now describing how it plans to integrate technology with Summa Health following its purchase of the hospital network. The firm says the focus will be o…
    Endpoints · 1mo agoNeutral↗ source
  • FDA approves Ultragenyx's gene therapy for Sanfilippo syndrome type A
    The FDA granted full approval to a rare disease gene therapy from Ultragenyx on Thursday, giving the company a much-needed boost in an otherwise difficult year. The therapy, called UX111, will be b…
    Endpoints · 1mo ago↗ source
  • Two more biotechs, Marea and North Immunology, do reverse mergers
    The reverse merger party is still buzzing. This time, it's a cardio and endocrine startup with two drugs in Phase 2 and a biotech working on a long-acting immunology and inflammation (I&I) drug. Mi…
    Endpoints · 1mo ago↗ source