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

By FM

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.

June 10, 2020 0

Ozanimod to treat adult patients with active MS

By FM

Bristol Myers Squibb announced that the European Commission (EC) has approved ozanimod (Zeposia) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease.