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.
All articles by Brian Park, PharmD
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.
Tarpeyo Now Available to Reduce Proteinuria in Primary IgA Nephropathy
To help patients gain access to treatment, Calliditas Therapeutics has launched a patient support program called Tarpeyo Touchpoints.
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