NDA Submitted for First-in-Class Acne Cream
Clascoterone is a topical androgen receptor inhibitor.
All articles by Steve Duffy
Guselkumab Superior to Secukinumab in Plaque Psoriasis Trial
According to results from the ECLIPSE trial, treatment with guselkumab was found to be superior to secukinumab in adult patients with moderate-to-severe plaque psoriasis based on 90% or better improvement in patients’ Psoriasis Area and Severity Index score compared to baseline (PASI 90 response).
NDA for Investigational Rosacea Treatment Submitted to FDA
FMX103 is a topical foam formulation of the antibiotic minocycline.
FDA Recalls Herbal Medications Being Marketed for Various Diseases
In addition to being manufactured outside of the controls required by current Good Manufacturing Practices, these products are also being marketed for diseases without FDA approval.
NDA Submitted for Novel Epithelioid Sarcoma Treatment
Epizyme has submitted a New Drug Application (NDA) for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.
CVS Pharmacy Introduces Third Party Testing for All Dietary Supplements
Vitamins and supplements sold at CVS Pharmacy will now go through third party testing to verify the accuracy of the dietary ingredients listed on the packaging and to confirm that the product is free of certain additives.
First Treatment for Children With Systemic Lupus Erythematosus Gets FDA Approval
The Food and Drug Administration (FDA) has approved the intravenous (IV) formulation of Benlysta (belimumab; GlaxoSmithKline) for the treatment of pediatric patients ≥5 years old with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
Skyrizi Approved for Moderate to Severe Plaque Psoriasis
The FDA has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Dupixent Approved to Treat Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
The FDA has approved the use of Dupixent (dupilumab; Sanofi and Regeneron) to treat moderate-to-severe atopic dermatitis in adolescent patients 12–17 years old.
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