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120 stories matching this filter · ← front page

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  • Roche signs $15 billion ADC partnership with China's Hansoh Pharma
    Roche has re-entered a partnership with China's Hansoh Pharmaceutical, signing a $15 billion biobucks agreement. The deal covers a broad portfolio of antibody-drug conjugate programs, including tw…
    Fierce Biotech · 1d agoDealPositive↗ source
  • TCGX uses SPAC to take migraine biotech TriGemX public, securing $246M for phase-3 trial
    TCGX, a life‑sciences investment firm, announced it will merge its SPAC with TriGemX Bio, a biotech focused on migraine treatments. TriGemX, formerly known as Kallyope, is developing a TRPM8 chann…
    Fierce Biotech · 1d agoDealPositive↗ source
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fda medwatch89
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Ophthalmology843
Endocrinology & Metabolism686
Pain650
Nephrology633
  • Iambic Therapeutics CEO discusses $150 million IPO and AI's evolving role in drug development
    Iambic Therapeutics completed a $150 million initial public offering, raising fresh capital and seeing its share price climb to about $24.50, roughly a 50% increase from earlier in the week. CEO T…
    BioPharma Dive · 4d agoDealPositive↗ source
  • City Therapeutics raises $200 million in IPO to fund next-gen RNAi programs
    City Therapeutics, a biotech focused on RNA interference, completed a $200 million initial public offering, selling about 11.1 million shares at $18 each. The proceeds will back three drug candida…
    BioPharma Dive · 4d agoDealPositive↗ source
  • AstraZeneca signs $1.5B AI partnership with insitro to discover liver and heart disease targets
    AstraZeneca announced a partnership with insitro, a biotech that uses artificial intelligence, with an upfront payment of $40 million and potential milestones up to $1.46 billion. The collaboratio…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Bausch + Lomb CEO Brent Saunders exits again, interim CEO Thomas Appio appointed
    Bausch + Lomb announced that CEO Brent Saunders is leaving the eye health company for a second time, less than four years into his latest tenure. The departure was mutually agreed upon by Saunders…
    Fierce Biotech · 4d agoNeutral↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 6d agoRegulatoryPositive↗ source
  • OMass Therapeutics secures $310M Series C, eyes status as Britain’s leading biotech
    OMass Therapeutics, an Oxford‑based biotech still in pre‑clinical stage, announced a new financing round that brings in $310 million. The series C, co‑led by Bain Capital Life Sciences, Forbion an…
    Fierce Biotech · 6d agoDealPositive↗ source
  • iOnctura’s roginolisib shows encouraging phase 1 results in metastatic uveal melanoma
    iOnctura, a spinout of Merck KGaA, reported data from a two‑part phase 1 trial of its PI3K delta inhibitor roginolisib in patients with advanced solid and hematologic cancers, including a cohort of…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision
    Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for Ju…
    Fierce Biotech · 8d agoRegulatoryPositive↗ source
  • Merck’s deeper dive into efficacy, safety of $1.3B eye disease drug raises fears of ‘limited’ potential
    Merck & Co. has poured out its Brunello data, revealing a mix of undifferentiated efficacy and concerning safety that led analysts to predict “limited competitive potential” in diabetic macular ede…
    Fierce Biotech · 8d agoRegulatoryNeutral↗ source
  • Bausch + Lomb appoints board chair Thomas Appio as interim CEO after Brent Saunders departs
    Bausch + Lomb announced that board chair Thomas Appio will serve as interim chief executive, taking over immediately from Brent Saunders, who is leaving the role. Appio, who has held several leade…
    BioPharma Dive · 8d agoNeutral↗ source
  • Parkinson’s-focused Aspen and bispecific biotech Bambusa plan IPOs
    Parkinson’s disease cell therapy-focused Aspen Neuroscience and bispecific biotech Bambusa Therapeutics are the latest drug developers to eye up a public listing.
    Fierce Biotech · 10d ago↗ source
  • Fierce Biotech outlines criteria for its 2026 Fierce 15 list, spotlighting top innovators
    The Fierce Biotech editorial team released its 2026 Fierce 15 list and discussed the selection process on a recent episode of "The Top Line" podcast. More than 150 high‑quality entries were review…
    Fierce Biotech · 11d agoPositive↗ source
  • Nobel-winning optogenetics sees growing biotech interest
    Karl Deisseroth, a Stanford psychiatrist and bioengineer, learned he had shared the 2026 Nobel Prize in Physiology or Medicine for pioneering optogenetics, a method that makes neurons responsive to…
    Fierce Biotech · 11d agoPositive↗ source
  • Argenx shares tumble 15% after Phase 3 Sjögren’s study of Vyvgart halted for futility
    Argenx reported that an independent monitoring board recommended stopping its Phase 3 trial of Vyvgart in Sjögren’s disease due to futility, based on an interim analysis. The decision came earlier…
    BioPharma Dive · 12d agoNegative readoutNegative↗ source
  • Atsena reports early efficacy signals for gene therapy ATSN-201 in X-linked retinoschisis trial
    Atsena Therapeutics presented data from the early parts of its Lighthouse gene therapy trial for X-linked retinoschisis (XLRS) at the American Academy of Ophthalmology meeting. The trial administe…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • iRegene Therapeutics’s NouvSight001 Cleared for Clinical Trials in the U.S. and China for Retinitis Pigmentosa
    Following its Parkinson’s disease program, iRegene advances another off-the-shelf cell therapy into clinical development in the U.S. and China.
    Fierce Biotech · 13d agoNeutral↗ source
  • Genmab’s Rina-S ADC shows 9.5-month median PFS, touted as superior to AbbVie’s Elahere
    Genmab reported median progression‑free survival of 9.5 months for its FRα‑directed antibody‑drug conjugate Rina‑S in part C of the phase 1/2 Rainfol‑01 trial, which enrolled 109 patients with plat…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Scientists awarded 2026 Nobel Prize for pioneering optogenetics light-switch technique
    The 2026 Nobel Prize in Physiology or Medicine was awarded to Karl Deisseroth, Peter Hegemann and Georg Nagel for their work on optogenetics, a technique that uses light to control neurons. The me…
    Fierce Biotech · 15d agoPositive↗ source
  • Kodiak Sciences' Zenkuda shows non-inferior six-month dosing vs Eylea, shares double
    Four years ago Kodiak Sciences saw its share price plunge about 80% after its lead eye-disease candidate failed a head-to-head trial against Regeneron's Eylea, wiping out roughly $2 billion in mark…
    BioPharma Dive · 18d agoPositive readoutPositive↗ source
  • VertigoDx receives FDA 510(k) clearance for its portable SmartVertigo diagnostic system
    The U.S. Food and Drug Administration has issued a 510(k) clearance for VertigoDx's portable vertigo assessment tool, allowing it to be marketed in the United States. The system, called SmartVerti…
    Fierce Biotech · 20d agoRegulatoryPositive↗ source
  • Kodiak Sciences' Phase 3 eye drug data beats Regeneron’s Eylea, shares double
    Kodiak Sciences reported that its two experimental treatments for macular degeneration met the primary endpoints in a Phase 3 trial that directly compared them with Regeneron’s Eylea. The data show…
    BioPharma Dive · 22d agoPositive readoutPositive↗ source
  • Genentech CEO Ashley Magargee reflects on biotech origins and future amid growing startup ecosystem
    Genentech’s founder story was revisited in a recent interview with CEO Ashley Magargee. She recalled how co‑founder Herbert Boyer was initially skeptical of a brief meeting with venture capitalist…
    Fierce Biotech · 21d agoPositive↗ source
  • Kodiak Sciences' eye disease drug matches Eylea in Phase 3, sending stock soaring
    Kodiak Sciences reported that two of its eye‑disease candidates performed on par with aflibercept (Eylea) in a pivotal Phase 3 trial. The data suggest comparable efficacy in treating the targeted r…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source