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64 stories matching this filter · ← front page

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  • Novo Nordisk's ziltivekimab fails phase 3 trial, jeopardizing CKD program
    Novo Nordisk reported that its phase 3 Zeus trial of the IL‑6 ligand antibody ziltivekimab did not meet its primary endpoint, a setback for the drug's development. The study enrolled more than 6,3…
    Fierce Biotech · 11h agoNegative readoutNegative↗ source
  • 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 · 1d agoNegative readoutNegative↗ source
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fda recalls22
fda press21
fda medwatch17
570
Vaccines516
Endocrinology & Metabolism290
Ophthalmology255
Infectious Disease253
Nephrology239
  • Legend Biotech CEO Ying Huang resigns abruptly, board taps interim leader
    Legend Biotech announced that its chief executive, Dr. Ying Huang, has stepped down unexpectedly, leaving the role vacant. Huang, who moved from chief financial officer to CEO in 2020 after a cust…
    Fierce Biotech · 1d agoNeutral↗ 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 · 2d agoRegulatoryNegative↗ source
  • FDA and Capricor clash over Duchenne cell therapy efficacy at advisory committee
    At an FDA advisory committee meeting, the agency and Capricor Therapeutics presented conflicting views on the efficacy data for the company's experimental cell therapy aimed at Duchenne muscular dy…
    Endpoints · 2d agoRegulatoryNegative↗ source
  • 529 Commerce recalls Rooted in Rare Aquafaba Powder over possible undeclared egg allergen
    529 Commerce, LLC of Parkland, Florida announced a recall of its Rooted in Rare brand Aquafaba Powder. The recall includes 3,860 units packaged in 4‑oz and 12‑oz flexible foil pouches that were so…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • 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 · 3d 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 · 4d 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 · 4d 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 · 4d agoNeutral↗ source
  • Updated: AstraZeneca foresees blockbuster sales for Claudin 18.2 ADC, but Ultomiris flops in rare disease
    AstraZeneca said Monday that a key late-stage trial of its Claudin 18.2-targeting ADC in stomach cancer had succeeded, albeit with a caveat — but another Phase 3 trial of Ultomiris yielded subpar r…
    Endpoints · 4d agoNeutral↗ source
  • Amgen submits new analysis to FDA to defend continued availability of Tavneos
    Amgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns. The company says the independent reevaluation supports the dr…
    Endpoints · 7d agoRegulatoryNeutral↗ 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 · 7d agoLayoffsNegative↗ source
  • Ipsen's Bylvay fails Phase 3 trial in children with biliary atresia
    Ipsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants. Biliary atresia is a rare pediatric liver disorder i…
    Endpoints · 7d agoNegative readoutNegative↗ source
  • CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa
    Minoryx Therapeutics finally scored backing from EU regulators for its neurological drug that’s faced multiple hurdles. Meanwhile, Zevra’s rare disease drug got a setback in Europe almost two years…
    Endpoints · 7d ago↗ 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 · 7d ago↗ source
  • From Abu Dhabi to Brazil, every region is vying for the ‘new emerging economy’ of biotech
    Whether it's looming tariff threats or the rise of China, you need a truly global view to navigate today's biopharma industry.
    Fierce Biotech · 8d 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 · 8d ago↗ source
  • Midwest Poultry Services. L.P. Recalls Shell Eggs Due to Possible Salmonella Enteritidis Contamination
    Midwest Poultry Services, L.P. is voluntarily recalling 1,589,577 dozen white shell eggs and brown cage free shell eggs produced in Texas because they have the potential to be contaminated with Sal…
    fda recalls · 8d 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 · 9d 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 · 9d 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 · 10d 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 · 10d ago↗ source
  • Broad Institute launches Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard is teaming up with Boston Children’s Hospital and The Jackson Laboratory to launch a new center focused on genetic treatments for rare diseases, the triumvira…
    Endpoints · 10d 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 · 11d ago↗ source