Ready-to-Use, Room Temp Stable, Premixed Vancomycin Injection Gets FDA Approval
Xellia announced that the Food and Drug Administration (FDA) has approved its Premixed Vancomycin Injection in a Ready-to-Use bag.
All articles by Da Hee Han
FDA Issues Complete Response Letter Rejecting Iclaprim Approval for ABSSSI
The NDA included data from the Phase 3 REVIVE-1 and REVIVE-2 trials.
Lexette Foam Now Available for Plaque Psoriasis
Lexette (halobetasol propionate) foam 0.05% has been made available for patients 18 years of age and older for the topical treatment of plaque psoriasis.
Nuzyra Now Available in IV, Oral Forms for CABP, ABSSSI
Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.
Seysara Now Available for Moderate to Severe Acne Vulgaris
The approval was based on data from 2 large, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials involving patients with moderate to severe acne vulgaris.
Keytruda Gains Merkel Cell Carcinoma Indication
The Food and Drug Administration has granted accelerated approval to Keytruda (pembrolizumab; Merck) for the treatment of patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
Baricitinib Gets Fast Track Status for Systemic Lupus Erythematosus
Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
Guselkumab Compared With Secukinumab in Head-to-Head Plaque Psoriasis Trial
In the ECLIPSE study (N=1048), patients were randomized to receive guselkumab 100mg at weeks 0, 4, and 12 followed by every 8-week dosing or secukinumab 300mg at weeks 0, 1, 2 3, 4 followed by every 4-week dosing.
New Topical Steroid Option for Plaque Psoriasis Soon to Be Available
The approval was supported by data from 2 prospective, multicenter, randomized, double-blind clinical trials.
Dupilumab Gets Priority Review for Adolescent Atopic Dermatitis
Dupixent is also being assessed in other allergic/inflammatory conditions, including pediatric atopic dermatitis, pediatric asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, and peanut allergy.
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