The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile
FOP is a rare genetic disorder caused by mutations in the ALK2 kinase
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Additional investments planned to expand the site’s capacity and capabilities to support growing manufacturing programs
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
SGX945 delivered beneficial effects in 7 of 8 patients suffering from painful oral ulcers
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
This marks the first partnership between Pfizer and Cipla in India
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