The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
The EMBOLD study evaluated relutrigine for patients with SCN2A and SCN8A developmental and epileptic encephalopathies
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
Here's a development that aims to keep your blood pressure in check. Literally!
Seeing well-controlled Phase 3 data that shows a marked slowing of lesion growth in Stargardt disease is deeply encouraging
Presbyopia, the age-related loss of near vision, could soon be treated successfully
This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
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