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
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
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
If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population
Usage of Synaffix GlycoConnect, HydraSpace and toxSYN ADC technologies to enhance efficacy, tolerability and target engagement
The certification marks a new chapter in Windlas Biotech’s growth trajectory,
The site’s GMP Certification has been successfully renewed
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