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
Morepen Laboratories approves hiving off of medical devices business
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
The combined entity will leverage its complementary strengths to deliver unparalleled solutions in protein purification and stabilization
PROVIGIL and NUVIGIL are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy
Dr. Smith brings 30 years of clinical and translational research experience in obesity, diabetes, and metabolism with over 300 scientific publications
Investment will fund expansion to meet rising demand for CRDMO services
Usage of Synaffix GlycoConnect, HydraSpace and toxSYN ADC technologies to enhance efficacy, tolerability and target engagement
According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually
The site’s GMP Certification has been successfully renewed
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