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19 stories matching this filter · ← front page

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  • Leo Pharma to license Tanabe’s oral drug for rare light-sensitive skin disease, paying up to $435 million
    Leo Pharma announced a licensing agreement with Japan's Tanabe Pharma for an oral treatment targeting two genetic skin disorders that cause pain when exposed to sunlight. Under the deal, Leo Pharm…
    Endpoints · 2d agoDealNeutral↗ source
  • Merck's anti-TL1A antibody shows benefit in hidradenitis suppurativa but misses endpoint in rare lung disease trial
    Merck reported mixed results from its anti‑TL1A antibody, a product of its $10.8 billion acquisition of Prometheus Biosciences. In a mid‑stage study for hidradenitis suppurativa, the antibody met…
    Endpoints · 15d agoNeutral↗ source
73
fda recalls47
fda medwatch36
fda press28
885
Psychiatry & CNS708
Ophthalmology416
Pain371
Endocrinology & Metabolism370
Infectious Disease346
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 17d agoRegulatoryNeutral↗ source
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • Sanofi halts development of Kymab-derived OX40L antibody for atopic dermatitis
    Sanofi announced that it will no longer pursue the OX40L antibody program it was developing with Kymab for the treatment of atopic dermatitis. The drug was being positioned as a potential follow‑on…
    Endpoints · 26d agoNegative↗ source
  • Celldex halts development of mast cell antibody after Phase 2 failure in prurigo nodularis
    Celldex announced it will discontinue the clinical program for its mast cell‑targeting monoclonal antibody aimed at treating prurigo nodularis, a chronic itchy‑skin condition. The decision follows…
    Endpoints · 28d agoNegative readoutNegative↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 1mo ago↗ source
  • Evommune's lead drug fails in chronic hives, stock sinks
    Evommune's shares {$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
  • 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 · 2mo 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 · 2mo 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 · 3mo ago↗ source
  • Dr Postow on an Ideal Post-ICI Monitoring Framework in Melanoma
    Michael A. Postow, MD, discusses the importance of long-term multidisciplinary follow-up for patients with melanoma treated with ICIs.
    onclive · 3mo ago↗ source
  • Five Under 5: Top Oncology Videos for the Week of 5/3
    The top 5 OncLive TV videos of the week cover insights in ovarian cancer, classical Hodgkin lymphoma, pancreatic cancer, melanoma, and myelofibrosis.
    onclive · 3mo 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 · 3mo 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