Regulatory Updates

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FDA Approves Gene Therapy for Rare Disease MDL

March 18th 2024

Lenmeldy (atidarsagene autotemcel) is the first gene therapy to treat children with juvenile metachromatic leukodystrophy (MLD).

FDA Sets Action Date for Resubmitted Lymphir in Rare Skin Cancer
FDA Sets Action Date for Resubmitted Lymphir in Rare Skin Cancer

March 18th 2024

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FDA Approves Tevimbra for Esophageal Cancer

March 15th 2024

FDA Approves Breyanzi for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
FDA Approves Breyanzi for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

March 15th 2024

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FDA Approves Rezdiffra, First Drug for NASH

March 15th 2024

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