Drug Approval | January 16, 2025
Alembic announces USFDA final approval for Brexpiprazole Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
The conference featured comprehensive discussions, field visits, and knowledge-sharing sessions addressing different aspect of major NCDs
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
PROVIGIL and NUVIGIL are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy
The overall clinical efficacy of Zaynich across indications was 98% at the test-of-cure
Lonza to develop spray-dried formulations for an intranasally-delivered biologic for Iconovo at its Center of Excellence for bioavailability enhancement and inhaled delivery in Bend (US)
Investment will fund expansion to meet rising demand for CRDMO services
Modi remarked that more than 20 illustrious research institutions such as IISc, IITs, CSIR and DBT-BRIC have played a major role in this research
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