Regulatory Updates

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FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa

April 22nd 2024

Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.

FDA Approves Pen Form of Entyvio for Crohn’s Disease
FDA Approves Pen Form of Entyvio for Crohn’s Disease

April 19th 2024

FDA Approves Stelara Biosimilar, Selarsdi

April 18th 2024

FDA Approves GSK's BLA for 5-in-1 Meningococcal Vaccine

April 17th 2024

Fasenra Approved for Children with Severe Asthma
Fasenra Approved for Children with Severe Asthma

April 11th 2024

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