Tag: Food & Drug Administration
FDA Approves Praxbind to Reverse Pradaxa’s Effect
Praxbind cleared for emergency use with Pradaxa when bleeding can't be controlled
FDA Approves Optune Device for Newly Diagnosed Glioblastoma
Newly sanctioned to treat just-diagnosed patients, in combination with temozolomide
FDA OKs Long-Acting Atypical Antipsychotic for Schizophrenia
Aristada (aripiprazole lauroxil) is injected every four-to-six weeks
FDA Approves Keytruda for Advanced NSCLC
Approved for use with PD-L1 IHC 22C3 pharmDx test
FDA Approves Two New Medications for Diabetes
Tresiba and Ryzodeg approved for use in adults with type 1 and 2 diabetes mellitus
FDA Approves Lonsurf for Metastatic Colorectal Cancer
For patients with metastatic CRC previously treated with chemotherapy, biological therapy
FDA Approves New Drug for Schizophrenia, Bipolar Disorder
Vraylar is an atypical antipsychotic taken once a day
FDA Orders Tobacco Company to Stop Sales of New Cigarettes
Says products didn't meet requirement that they be substantially the same as existing cigarettes
FDA Announces New Steps to Improve Food Safety in U.S.
New rules focus on cleanliness of manufacturing facilities
FDA Issues Warning Regarding Injectable Skin Lighteners
Injectable products may contain unknown substances or contaminants