The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
The trials, which enrolled over 1,000 patients across 398 sites in 17 countries, showed that the drug was safe and well-tolerated—but ultimately failed to deliver the hoped-for clinical results
The EU approval of DAWNZERA is an important milestone that reflects our ongoing commitment to bring this innovative medicine to people in need across the globe
The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients
Company to launch product after the expiry of semaglutide patent in India
Galenicum will oversee development, manufacturing and supply, while Lupin will handle regulatory submissions, approvals, and commercialization and distribution of Semaglutide across 23 countries globally
Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells
Myqorzo, a selective small-molecule cardiac myosin inhibitor, is designed to improve functional capacity and relieve symptoms in oHCM
Improvements were also seen in complete response rates, duration of response, and time to next treatment
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