FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win
The renewal covers two versions of the IQOS device and three HEETS tobacco variants
The renewal covers two versions of the IQOS device and three HEETS tobacco variants
Clearing 19 biologics for Europe market
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
The approval is supported by results from the Phase 3 SWOG 1826 trial
The approval was granted by Agenzia Italiana del Farmaco
The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio
But acquisition charges drag earnings into loss
The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation
The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
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