News | December 12, 2025
Granules Life Sciences facility receives EIR from USFDA
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
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 Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
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
The new centre brings advanced corneal procedures pioneered in India
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
Subscribe To Our Newsletter & Stay Updated
