Opzelura Cream Approved for Nonsegmental Vitiligo
The approval was based on data from two phase 3 studies, which included patients 12 years of age and older with nonsegmental vitiligo who had depigmented areas.
All articles by Brian Park, PharmD
New Data Show Additional Clinical Benefits of COVID-19 Antiviral Molnupiravir
The trial included adults with mild to moderate COVID-19 with symptom onset within 5 days of randomization who were at high risk for progressing to severe disease.
FDA Approves Additional Option for Measles, Mumps and Rubella Vaccination
Priorix is administered as a 2-dose series (each dose is approximately 0.5mL) via subcutaneous injection.
Bristol Myers Squibb Withdraws Luspatercept sBLA for NTD Beta Thalassemia
The application included data from the phase 2 BEYOND study.
FDA Extends Review Period for Fixed-Dose Combo Therapy for ALS
The FDA extended the action date by 3 months to allow more time to review additional analyses of data from the Company’s clinical studies.
FDA to Review Data on Long-Term Use of Myfembree for Uterine Fibroids
The study enrolled women who completed the 24-week LIBERTY 1 and 2 studies and the 28-week open-label extension studies, and who met the definition of a responder.
FDA Extends Shelf Life of On-Demand Contraceptive Phexxi
Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Trial Evaluating Zuranolone for Postpartum Depression Meets All Endpoints
Zuranolone is an investigational oral neuroactive steroid GABA-A receptor positive allosteric modulator.
Lyvispah Now Available for Spasticity Due to MS, Other Spinal Cord Disorders
The approval was based upon a bioavailability study in healthy adults comparing baclofen oral tablets to Lyvispah.
Dupilumab Gets Priority Review for Prurigo Nodularis
The sBLA is supported by data from the phase 3 PRIME2 and PRIME trials that assessed dupilumab in patients 18 years of age and older with prurigo nodularis.
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