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Recent Articles

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FDA receives more than 100 adverse event reports related to children and adults who consumed edible products containing THC, including hospitalizations

FDA approves Alembic Pharmaceuticals’ ANDA for arformoterol tartrate inhalation solution, 15 mcg/2 mL unit-dose to treat chronic obstructive pulmonary bronchoconstriction; drug is therapeutic equivalent of Sunovion Pharmaceuticals’ Brovana

FDA gives breakthrough therapy designation to Zambon’s inhaled colistimethate sodium powder to treat pulmonary exacerbations in non-cystic fibrosis bronchiectasis; treatment uses adaptive aerosol delivery battery-powered I-neb nebulizer

FDA approves Hologic’s Aptima CMV Quant assay for use with Hologic’s automated Panther system for solid organ, stem cell transplant patients; test is firm's first post-transplant pathogen detection test in US, joins tests for HIV-1, hepatitis C and B

FDA approves Eli Lilly’s oral Olumiant as a standalone COVID-19 treatment for hospitalized adult patients using supplemental oxygen or ventilation; Olumiant has treated over one million patients with sales up from US$437.0M in 2019 to US$1.1B in 2021

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