FDA completes inspection of SMS Pharma’s Vizag facility
The inspection concluded with one minor observation in Form 483
The inspection concluded with one minor observation in Form 483
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled
The FDA aims to make a decision by April 8, 2026
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
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