U.S FDA

Summary Taiwan Food and Drug Administration (TFDA) has accepted the New Drug Application/Orphan Drug Registration (NDA/ODR) for CAN108 (maralixibat oral solution (LIVMARLI TM))…

Synopsis : IQVIA announced an agreement today with argenx SE. The multi-year contract covers a unique collaboration for the development of new…

Summary : Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol…

Summary : The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending…

Summary : AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic…

Summary : Alembic Pharmaceuticals received a tentative approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug…

Summary : Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility. Sanofi has…

Summary : It’s an understatement to note that the bottom lines for Moderna and Pfizer have been fattened by the success of…

Summary : The U.S. Food and Drug Administration turned down Ocugen’s Emergency Use Authorization (EUA) request for Covaxin in children 2 to…

Highligts : Sevelamer Hydrochloride Tablets, 800 mg is a generic equivalent of Renagel Tablets, 800 mg of Genzyme Corporation used in the…