January 23, 2020
January 23, 2020 – The U.S. FDA has granted accelerated approval to TazverikTM (tazemetostat),
manufactured by Epizyme, to treat patients who are at least 16 years old and have metastatic or locally
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January 21, 2020
January 21, 2020 – The U.S. FDA has approved TepezzaTM (teprotumumab-trbw), manufactured by Horizon
Therapeutics, to treat thyroid eye disease (TED). It is the first and only FDA-approved therapy for this
indication.
January 20, 2020
January 20, 2020 – The U.S. FDA has approved MonoferricTM (ferric derisomaltose) injection, manufactured by Pfizer, to treat iron deficiency anemia in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron, as well as adult patients who have
January 16, 2020
January 16, 2020 – The U.S. FDA has approved an update to the label for Rybelsus® (semaglutide) tablets, manufactured by Novo Nordisk. The label now includes data from the PIONEER 6 cardiovascular outcomes trial demonstrating cardiovascular safety.
January 16, 2020
January 16, 2020 – The U.S. FDA has approved a new indication for Ozempic® (semaglutide) injection
0.5mg or 1mg, manufactured by Novo Nordisk. Ozempic is now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as heart
January 14, 2020
January 14, 2020 – Drug manufacturer Eli Lilly has announced that it will offer lower price versions of its
brand name insulin products Humalog® Mix75/25TM KwikPen® (insulin lispro protamine/insulin
January 14, 2020
January 14, 2020 – The U.S. FDA has issued a safety communication regarding Arena Pharmaceuticals’
Belviq® (lorcaserin) and Belviq® XR (lorcaserin extended release). According to the agency, these drugs may increase patients’ risk of cancer.
January 13, 2020
January 13, 2020 – The U.S. FDA has approved Numbrino® (cocaine hydrochloride nasal solution 4%), a nasal spray manufactured by Lanett Company and indicated to provide local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.