This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company
LEQEMBI was initially approved in China in January 2024 for the treatment of Alzheimer’s disease in patients with mild cognitive impairment
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The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.
Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion
Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent
Merck opens first climate-neutral manufacturing facility in Ireland
ABP-745 is a novel oral therapy with potential applications in cardiovascular and other inflammatory diseases
Tegoprazan, a novel patented molecule indicated for acid-related gastrointestinal diseases, is launched in India under the brand name PCAB
NouvNeu001 is the world’s first allogeneic iPSC-derived cell therapy for Parkinson’s disease to receive this designation
The Ma’anshan site approval covers pastilles, oral liquids, and powders
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