Drug Approval | June 23, 2025
Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
The company will provide the necessary response to USFDA within stipulated 15 days
The company will provide the necessary response to USFDA within stipulated 15 days
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
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
BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
SUP will obtain regulatory approvals for selling Tiotropium DPI in China
Innovative agents highlight growth of targeted protein degradation platform and BMS' leadership in innovative cancer therapies
The collaboration furthers AstraZeneca’s presence in China following the $2.5bn investment in Beijing
Now approved for both acute and chronic HCV in adults and children aged 3 and above
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