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
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
Biocon Biologics remains committed to global standards of quality and compliance
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
Usage of Synaffix GlycoConnect, HydraSpace and toxSYN ADC technologies to enhance efficacy, tolerability and target engagement
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