The U.S. Food and Drug Administration (FDA) has granted traditional approval to Novartis for Fabhalta (iptacopan), a groundbreaking oral Factor…
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Sobi Receives Complete Response Letter from FDA for Investigational Gout Therapy NASP, Focus on Manufacturing Deficiencies
Swedish Orphan Biovitrum (Sobi) has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning…
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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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Datroway Receives FDA Approval for Metastatic Triple-Negative Breast Cancer, Marking a Significant Advancement in Targeted Therapy
The US Food and Drug Administration (FDA) has granted a pivotal approval for Datroway (datopotamab deruxtecan), a novel antibody-drug conjugate…
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VERTANICAL’s Investigational Non-Opioid Chronic Low Back Pain Treatment VER-01 Receives FDA Breakthrough Therapy Designation
VERTANICAL has announced a significant milestone in its development of VER-01, an investigational non-opioid therapeutic candidate for chronic low back…
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Sanofi Receives FDA Approval to Expand Tzield Use in Children as Young as One Year for Type 1 Diabetes Delay
Sanofi has secured a significant expansion of its U.S. Food and Drug Administration (FDA) approval for Tzield (teplizumab-mzwv), a groundbreaking…
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Wegovy HD Receives FDA Approval Amidst Looming Patent Expiries in Key Markets
The U.S. Food and Drug Administration (FDA) has granted approval for a higher-dose formulation of Novo Nordisk’s blockbuster weight-loss medication,…
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