TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
The company received seven observations in the Form-483
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
SUP will obtain regulatory approvals for selling Tiotropium DPI in China
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Sun Pharma gets 8 observations from USFDA for Halol facility
Innovative agents highlight growth of targeted protein degradation platform and BMS' leadership in innovative cancer therapies
Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression
The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities
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