SPOTLIGHT -
New indication: Biologic cleared for psoriatic arthritis
FDA Approves Second Biosimilar of Actemra
The new biosimilar, Tyenne, was approved in both an IV and a subcutaneous forms to treat inflammatory conditions such as arthritis.
Celltrion USA Seeks Approval for Actemra Biosimilar
Celltrion’s application is based on data from a phase 3 trial of patients with rheumatoid arthritis comparing its biosimilar with Actemra.
FDA Sets Review Date for Zoryve in Atopic Dermatitis
The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.
Dupixent Gets Complete Response Letter for Inflammatory Skin Disorder
The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.
Zoryve is Now Approved for Children with Plaque Psoriasis
The dosage of Zoryve for children 6 to 11 is the same as for those over the age of 12. The list price is same for both pediatrics and adults — $825 per tube.
Manufacturing Issues Lead to CRL for Liquid Botulinum Toxin
Galderma officials said they have already identified changes to its manufacturing process for relabotulinumtoxinA, which is being reviewed as a treatment for frown lines and crows feet.