Expanded Label Archives

FDA Approves Expanded Indication for Keytruda in Locally Advanced cSCC

Blockbusters, Clinical Trials, Cutaneous Squamous Cell Carcinoma (CSCC), Expanded Label, FDA, Keytruda, Label Expansion, PD-1 Inhibitors, R&D, Therapeutics

The U.S. Food and Drug Administration approved an expanded label for Merck’s anti-PD-1 therapy Keytruda as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

July 6, 2021/by Andrew Humphreys

FDA Approves Labeling Supplement for Puma Biotechnology’s Breast Cancer Drug Nerlynx

Biopharmaceutical, Expanded Label, FDA, FDA/Regulatory, HER2 protein, HER2-Positive Early Breast Cancer

Puma Biotechnology Inc. announced that the U.S. Food and Drug Administration approved a labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer.

October 2, 2019/by Business Wire

FDA approves expanded label for Regeneron/Sanofi’s Dupixent

Analysts, Approvals, Asthma, Atopic Dermatitis (Eczema), Biologics, Blockbusters, Chronic Obstructive Pulmonary Disease (COPD), Chronic Rhinosinusitis, Corticosteroids, Environmental Allergies, Eosinophilic Esophagitis, Expanded Label, FDA, FDA/Regulatory, Food Allergies, Nasal Polyps

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.

June 26, 2019/by Reuters Health

FDA approves expanded label for Praluent

"Bad" LDL Cholesterol, Approvals, Biotech, Cardiovascular Events, Cholesterol, Drug Pricing, Expanded Label, FDA, FDA/Regulatory, Heart Attacks, Heterozygous Familial Hypercholesterolemia (HeFH), Injectables, Major Adverse Cardiovascular Events (MACE), PCSK9 inhibitors, Statins, Stroke

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals’ cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events.

April 26, 2019/by Reuters Health