News

The FDA approved the first biosimilar of the arthritis medication Actemra, as well as plaque psoriasis drug Zoryve for children. The agency issued a complete response letter for lebrikizumab in atopic dermatitis and for liquid formulation of botulinum toxin for frown lines, and assigned a review date for a gene therapy for a rare immune disorder. Additionally, Takeda plans to withdraw the oncology drug Exkivity from the market while Coherus resubmits BLA for Udenyca OnBody.

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The FDA has approved several new therapies this week, including a new two-component Pompe therapy, an extended-release drug for major depression without sexual side effects, and an eye drop for drug-induced dilation. Additionally, the agency has set review dates for several products, including odronextamab for blood cancers, sotatercept for pulmonary arterial hypertension, and Dupixent in young children with eosinophilic esophagitis.

The FDA has approved GSK’s myelofibrosis drug, as well as a new indication for Jardiance and a new dosing regimen for Talicia. The agency has also issued a complete response letter for epinephrine nasal spray and assigned a review date for the gene therapy atidarsagene autotemcel.