Tag Archives: approves

FDA Approves Gattex (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)

Print this page Lexington, MA, May 17, 2019 – Takeda Pharmaceuticals, U.S.A., Inc. (“Takeda”), announced today that the U.S. Food and Drug Administration (FDA) approved extending the indication of Gattex (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous… Read More »

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters Print this page Brussels (Belgium) & Atlanta, Georgia (U.S.) – May 20 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company’s newest anti-epileptic drug (AED) Nayzilam (midazolam) nasal spray CIV, a benzodiazepine indicated… Read More »

FDA approves expanded label for Regeneron/Sanofi’s cholesterol drug

(Reuters) – The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Inc’s cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events. The FDA’s decision will allow the drug, developed along with Sanofi SA, to be prescribed to reduce the overall risk of major… Read More »