FDA actions in brief
An estradiol transdermal gel (Elestrin [formerly Bio-E-Gel], Bradley/BioSante) was approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
An estradiol transdermal gel (Elestrin [formerly Bio-E-Gel], Bradley/BioSante) was approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
FDA approved calcium hydroxylapatite (Radiesse, BioForm Medical) for the long-lasting correction of moderate-to-severe facial wrinkles and folds and for the long-lasting correction of facial lipoatrophy in patients with HIV.
A kit containing hydroxocobalamin, intravenous tubing, and a sterile spike for reconstituting the drug product with saline (Cyanokit, EMD/Dey) was approved for the treatment of known or suspected cyanide poisoning.
A new refrigerated formulation of influenza virus vaccine live, intranasal (FluMist, MedImmune) was approved for the active immunization for the prevention of disease caused by influenza A and B viruses in healthy children, adolescents, and adults.
FDA approved formoterol inhalation powder (Foradil Certihaler, Novartis/SkyePharma) for the treatment of asthma and the prevention of bronchospasm in adults and children aged ≥5 years with reversible obstructive airway disease.
FDA Expands Kerendia’s Use to Treat Common Form of Heart Failure
July 14th 2025Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic kidney disease (CKD) associated with type 2 diabetes. This new approval extends its use to a broader patient population.
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