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
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The FDA aims to make a decision by April 8, 2026
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
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