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13 stories matching this filter · ← front page

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  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 20h agoPositive readoutPositive↗ source
  • Celldex scraps antibody in prurigo nodularis after Phase 2 flop
    Celldex said on Tuesday it will stop investigating its mast cell-targeting monoclonal antibody in a type of chronic itch disease after it failed on all efficacy measures in a mid-stage trial. Topli…
    Endpoints · 9d ago↗ source
28
fda recalls22
fda press21
fda medwatch17
570
Vaccines506
Endocrinology & Metabolism288
Ophthalmology254
Infectious Disease247
Pain232
Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
fda medwatch · 25d ago↗ source
  • Evommune's lead drug fails in chronic hives, stock sinks
    Evommune's shares {$EVMN} fell more than 30% on Monday morning after the biotech reported its first major trial readout since going public last year. In chronic spontaneous urticaria, a skin condit…
    Endpoints · 1mo ago↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 1mo ago↗ source
  • Takeda's plaque psoriasis pill beats Bristol Myers' Sotyktu in Phase 3
    Takeda’s $4 billion bet on an oral plaque psoriasis drug has paid off again, as the company reported the pill beat Bristol Myers Squibb’s Sotyktu in a head-to-head Phase 3 study. Zasocitinib induce…
    Endpoints · 1mo ago↗ source
  • FDA Expands Sunscreen Options for the First Time in 20 Years
    Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen i…
    fda press · 1mo ago↗ source
  • Supreme Court sides with Hikma in 'skinny label' case
    The Supreme Court unanimously sided with Hikma Pharmaceuticals and its “skinny label” version of a prescription-strength fish oil pill in a case that was closely watched by the generics industry. T…
    Endpoints · 1mo ago↗ source
  • Regeneron's Phase 3 skin cancer miss adds to mounting failures in LAG-3
    Regeneron Pharmaceuticals’ LAG-3 inhibitor called fianlimab has flunked a late-stage skin cancer trial, marking yet another blow for the drug class. The announcement follows a spate of recent clini…
    Endpoints · 2mo ago↗ source
  • Avalo scores Phase 2 success in comeback bid, raises $375M
    Avalo Therapeutics’ comeback bid surged forward Tuesday afternoon, as the immunology biotech secured a mid-stage trial win in an inflammatory skin disorder. Avalo said that both doses of an experim…
    Endpoints · 2mo ago↗ source
  • Supreme Court questions how far generics makers can go with 'skinny label' drugs
    WASHINGTON — Supreme Court justices gave a few hints about how they intend to rule in a divisive case for the pharmaceutical industry. In its final argument scheduled for this term, the high court…
    Endpoints · 3mo ago↗ source
  • Incyte claims double Phase 3 win in vitiligo, will file for approval
    Incyte intends to seek approval of its JAK1 inhibitor pill in the skin disease nonsegmental vitiligo after the drug, povorcitinib, hit in twin Phase 3 trials. The company revealed the successes ...
    Endpoints · 3mo ago↗ source
  • Oruka posts Phase 2 win in psoriasis, hoping to compete with Skyrizi
    Oruka Therapeutics' Phase 2 psoriasis data could mean there's a future challenger to megablockbuster Skyrizi. The company said on Monday that 40 of 63 patients (63.5%) who took an experimental drug…
    Endpoints · 3mo ago↗ source