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26 stories matching this filter · ← front page

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  • Sanofi’s new CEO vows deeper review of late-stage pipeline after series of trial failures
    Sanofi appointed Belén Garijo as chief executive in February with a clear mandate to tighten R&D governance and boost productivity. The board tasked her with bringing more rigor to the company’s st…
    Fierce Biotech · 21h agoNegative readoutNegative↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
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fda medwatch21
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Psychiatry & CNS340
Ophthalmology169
Infectious Disease165
Pain160
Nephrology159
  • Incyte ditches phase 1-stage JAK inhibitor to pursue next-gen options
    Incyte has ditched a JAK2 inhibitor in phase 1 development for a rare blood cancer in favor of “next-generation” replacements.
    Fierce Biotech · 2d agoNeutral↗ source
  • After missed endpoint, Gossamer and Chiesi pull the plug on PAH drug collaboration
    After signing a deal worth up to $486 million with Italian biopharma Chiesi to develop its pulmonary arterial hypertension (PAH) candidate seralutinib in 2024, Gossamer Bio has ended the collaborat…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • RA Capital launches rare disease company Oak Hill Bio onto Nasdaq via SPAC
    Rare disease biotech Oak Hill is headed to the Nasdaq through a SPAC merger with RA Capital-sponsored Research Alliance Corporation III (RACC) to fund a rare genetic disease candidate.
    Fierce Biotech · 3d agoDealNeutral↗ source
  • ‘This could be a large market’: Novo Holdings-backed Claris secures $118M for corneal disease drug
    A new biotech has come into view with a $118 million series B and a vision for making the front of the eye front-of-mind.
    Fierce Biotech · 3d agoNeutral↗ source
  • Amgen cuts about 40 jobs, about 0.1% of workforce, amid ongoing challenges
    Amgen announced the layoff of roughly 40 employees, representing about 0.1% of its global staff, as part of organizational changes aimed at aligning operations with strategic objectives. The compan…
    Fierce Biotech · 6d agoLayoffsNegative↗ source
  • Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects
    A new analysis of patients who took part in clinical trials for Kite Pharma’s CAR-T cell therapy Yescarta has revealed genetic signatures of toxicity risk, potentially providing a path forward for…
    Fierce Biotech · 6d ago↗ source
  • Australian biopharma Clinuvel to shed up to 20% of workforce in move to US
    Australian biopharma Clinuvel Pharmaceuticals is moving its headquarters to the U.S.— but up to a fifth of the company’s workforce won’t be staying for the trans-Pacific pivot.
    Fierce Biotech · 7d ago↗ source
  • NIH joins Trump’s $5B AI mission with biomedical research push
    The U.S. Department of Health and Human Services announced new efforts Wednesday aligned with President Donald Trump’s artificial intelligence-driven Genesis Mission. The centerpiece of HHS’ partic…
    Fierce Biotech · 8d ago↗ source
  • Royalty Pharma pens $425M deal for slice of sales on AstraZeneca’s ATTR drug
    Royalty Pharma has secured a stake in another transthyretin-mediated amyloidosis drug, this time paying $125 million upfront to Neurimmune for a cut of the sales of its AstraZeneca-partnered med.
    Fierce Biotech · 8d ago↗ source
  • ‘We’re moving quickly’: Startup bags rare disease drug as Thiel-backed CEO eyes $50M fundraise
    A rare disease startup with a mission to repurpose proven drugs has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
    Fierce Biotech · 9d ago↗ source
  • Biotech industry leaders file brief backing FDA against ‘malicious’ mifepristone challenge
    A group of 61 biopharma companies, executives and investors has filed an amicus brief in support of the FDA in an ongoing case brought by Louisiana meant to remove access to the abortion pill mifep…
    Fierce Biotech · 9d ago↗ source
  • Genetic medicine luminaries launch new center for personalized therapies
    A team of veteran scientists from elite institutions has come together to form a new center dedicated to the crafting of personalized genetic medicines, adding to the growing list of similar effort…
    Fierce Biotech · 10d ago↗ source
  • ‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics
    After Eli Lilly dived into the psychedelics space with a $2.8 billion upfront acquisition of AtaiBeckley last week, industry experts told Fierce that the deal would give the space added momentum.
    Fierce Biotech · 12d ago↗ source
  • Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador
    Jasper Therapeutics is being reborn via a merger with Nasdaq-listed immune-mediated disease biotech Kira Pharmaceuticals.
    Fierce Biotech · 13d ago↗ source
  • Dimerix snaps up Mission’s stalled, phase 2-ready kidney disease candidate in $292M deal
    Dimerix has bought an acute kidney injury drug from Mission Therapeutics, paying $5 million upfront and committing up to $287 million in milestones for the phase 2-ready asset.
    Fierce Biotech · 13d ago↗ source
  • Chutes & Ladders—Cue lines up new CMO and research head
    Cue Biopharma is tapping in a new chief medical officer and head of R&D in Dominic Borie, M.D., Ph.D., a physician-scientist with over two decades of industry experience.
    Fierce Biotech · 14d ago↗ source
  • Why Axiom hopes it’s ‘solved 2 major potholes’ that have hurt other stem cell biotechs
    When Axiom's stem cell therapy demonstrated a 0% mortality rate over two years in potentially fatal newborn neurological diseases this week, the biotech's leadership saw a broader validation for th…
    Fierce Biotech · 15d ago↗ source
  • Building a workforce engine for biomanufacturing
    Ohio’s $30M training initiative aims to scale talent pipelines and power life sciences growth statewide.
    Fierce Biotech · 17d ago↗ source
  • FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
    fda press · 29d ago↗ source
  • FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
    The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…
    fda press · 1mo ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source
  • De-Risking a Rare Disease Launch Starts with Precision
    Why traditional models fall short in rare disease commercialization—and what works instead.
    Fierce Biotech · 1mo ago↗ source
  • FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients
    The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific a…
    fda press · 1mo ago↗ source