The US Food and Drug Administration (FDA) has accepted priority review of the new drug application (NDA) for Roche’s investigational…
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US FDA Grants Priority Review to Bristol Myers Squibb’s Camzyos for Adolescent Patients with Obstructive Hypertrophic Cardiomyopathy
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental new drug application (sNDA) for Camzyos…
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Sanofi’s Venglustat Receives Priority Review from US FDA for Type 3 Gaucher Disease
Sanofi has secured a significant milestone in its development of venglustat, an innovative oral glucosylceramide synthase inhibitor (GCSi), with the…
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Pfizer and Astellas Secure FDA Priority Review for Perioperative Padcev and Keytruda Combination in Muscle-Invasive Bladder Cancer
The United States Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) from…
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FDA Proposes Permanent Authorization of Rare Pediatric Disease Priority Review Voucher Program to Foster Regulatory Stability
The United States Food and Drug Administration (FDA) is making a significant move to permanently authorize the rare pediatric disease…
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The US Food and Drug Administration Convenes Public Hearing Amidst Scrutiny of Commissioner’s National Priority Voucher Program
The US Food and Drug Administration (FDA) is set to convene a significant public hearing on June 12, 2026, a…
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