Tag: Food & Drug Administration
FDA Approves Erleada to Treat Non-Metastatic Prostate Cancer
First FDA-approved treatment for non-metastatic, castration-resistant prostate cancer
FDA Says U.S. Will Now Produce Critical MRI Component
New technology approved to produce the country's own supply of the radioisotope Technetium-99m
FDA Approves Admelog for Diabetes
First drug approved as a follow-up product based on an abbreviated new process
FDA Approves Ozempic for Type 2 Diabetes
Novo Nordisk drug also found to help with weight loss
Shortest Development Time for Breakthrough Status Drugs
Shorter development time for breakthrough, non-fast-track versus fast-track, non-breakthrough drugs
FDA Approves Once-Monthly Injection for Opioid Addiction
Sublocade has been shown to reduce opioid withdrawal symptoms and the desire to use opioids
FDA Approves Biosimilar Ogivri for Breast, Stomach Cancers
Ogivri is approved to treat HER2+ breast and gastric or gastroesophageal junction adenocarcinoma cancers
FDA OKs Drug for Hemophilia A With Factor VIII Inhibitors
Weekly prophylactic treatment associated with substantial decrease in bleeding episodes
FDA Approves Drug With Digital Ingestion Tracking System
Aripiprazole tablets have embedded sensors so patients, physicians can track medication ingestion
Zelboraf Approved for Use in Erdheim-Chester Disease
Kinase inhibitor (vemurafenib) for use in patients with BRAF V600 mutation
