FDA Approves Second Formulation of Humira Biosimilar Cyltezo
May 1st 2024According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.”
FDA Accepts sNDA for Tapinarof Cream 1% for Treatment of Atopic Dermatitis
April 29th 2024The ADORING 3 phase 3 development program is currently studying the novel, aryl hydrocarbon receptor agonist as a once-daily, cosmetically elegant, and steroid-free topical cream for adults and children with atopic dermatitis.
FDA Expands Tenofovir Alafenamide Indication to Treat HBV in Patients as Young as 6
March 28th 2024Tenofovir alafenamide was originally approved by the FDA in 2016 to treat adults with chronic HBV infection with compensated liver disease and in 2022 to treat pediatric patients aged 12 years and older.