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10 stories matching this filter · ← front page

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STAT825Endpoints630BioPharma Dive240onclive165Fierce Biotech91BioSpace90raps32globenewswire health
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allOncology574Rare Disease284Immunology229Cardiology193Hematology159Pulmonology131Vaccines
  • 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 · 1d agoRegulatoryNegative↗ source
  • 529 Commerce LLC Recalls Rooted in Rare brand Aquafaba Powder due to Undeclared Eggs
    529 Commerce, LLC of Parkland, Florida is recalling 3,860 units of its 4oz and 12 oz packages of its Rooted in Rare brand Aquafaba Powder because the product may contain undeclared egg. People who…
    fda recalls · 1d ago↗ source
28
fda recalls22
fda press21
fda medwatch17
99
Psychiatry & CNS87
Ophthalmology86
Pain75
Endocrinology & Metabolism52
Dermatology51
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 · 3d 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 · 6d agoRegulatoryNeutral↗ 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 · 6d 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 · 6d 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 · 7d 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 · 9d ago↗ source
  • Relay Peak Research LLC Recalls Zen Principle® Moringa Capsules Because of Possible Health Risk
    Relay Peak Research LLC (Zen Principle Naturals) of Incline Village, NV is voluntarily recalling its Zen Principle® brand Moringa Capsules dietary supplement because the product has the potential t…
    fda recalls · 10d ago↗ source
  • FDA approves Regeneron's hearing loss gene therapy Otarmeni
    Regeneron has won the first-ever FDA approval for a gene therapy to treat a rare type of inherited hearing loss, and the company plans to offer the treatment for free in the US, though that ...
    Endpoints · 3mo ago↗ source