Regulatory Updates

Latest News

FDA Approves New Pompe Therapy
FDA Approves New Pompe Therapy

September 29th 2023

The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.

FDA Sets Review Date for Odronextamab to Treat Blood Cancers
FDA Sets Review Date for Odronextamab to Treat Blood Cancers

September 29th 2023

FDA Approves Extended-Release Therapy for Major Depression
FDA Approves Extended-Release Therapy for Major Depression

September 28th 2023

FDA Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension
FDA Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension

September 28th 2023

FDA Approves Drop for Drug-Induced Dilation of the Pupils
FDA Approves Drop for Drug-Induced Dilation of the Pupils

September 27th 2023

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