Tag: Food & Drug Administration
FDA Approves Cholbam for Rare Bile Acid Synthesis Disorders
Drug is approved as an oral treatment for children aged 3 weeks and older, and adults
FDA Updates Recs for Cleaning of Reusable Med Devices
Updated rules in response to contaminated duodenoscopes
FDA Approves Unituxin for High-Risk Neuroblastoma
First approval for a therapy aimed specifically to treat the rare pediatric cancer
FDA Approves Cresemba for Serious Fungal Infections
New drug targets cell walls of the fungi; available in oral and intravenous formulations
FDA Approves New CPR Devices
Used together, they up the amount of oxygenated blood circulating through the body during CPR
FDA: Device Authorized for Use in Dialysis-Related Amyloidosis
Lixelle Beta 2-microglobulin Apheresis Column authorized for use in DRA
FDA Approves First Biosimilar Drug in U.S.
Zarxio is highly similar to long-sanctioned cancer drug
FDA: Opdivo Approval Expanded to Include Lung Cancer
FDA approves drug for NSCLC patients who have been treated with platinum-based chemotherapy
FDA Approves New Combination Antibiotic Avycaz
Combination drug sanctioned for abdominal, urinary tract infections
FDA Approves Farydak for Multiple Myeloma
Drug is sanctioned for people who have received at least two prior standard therapies