Category: Drug Approvals

November 12, 2021 0

Made-in-India molnupiravir may get EUAs soon: Govt sources

By Team FM

Five Indian drugmakers, including Cipla, Dr Reddy’s Laboratories, Sun Pharmaceutical Industries, Torrent Pharmaceuticals and Emcure Pharma, had early this year signed separate non-exclusive voluntary licensing agreements with the inventor Merck Sharp & Dohme (MSD) for manufacturing and marketing this drug locally.

September 11, 2021 0

AK-OTOF to treat otoferlin gene-mediated hearing loss in EU

By Team FM

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the application for orphan drug designation for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss, Akouos, Inc announced.

May 8, 2021 0

Viloxazine for treatment of ADHD


Supernus Pharmaceuticals announced that the US FDA approved viloxazine extended-release capsules (Qelbree) for the treatment of attention-deficit hyperactivity disorder (ADHD) in paediatric patients 6 to 17 years of age.