Drug Approval | May 29, 2025
Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
Expanded US manufacturing and R&D presence with investment in 10 facilities, including 7 brand new facilities
Company expects to begin building four more domestic manufacturing sites this year and add 13,000 high-wage manufacturing and construction jobs in America
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo
The primary objective of the study is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs
Inaugurates new facilities to further NIMHANS’ mission of delivering cutting-edge care in mental health and neurosciences
Acquisition adds potential best-in-class disease-modifying therapy for Alzheimer's disease
Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS
Medanta is expected to incur a project capex of ~Rs. 600 crores in next 3-4 years
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