Tag: Food & Drug Administration
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
Calquence Approved for Mantle Cell Lymphoma
For patients who have not responded to at least one prior treatment or who have relapsed
Gene Tx Approved for Certain Types of B-Cell Lymphoma
First such treatment for certain types of non-Hodgkin lymphoma
