US FDA Approves Gilead Sciences Inc.’s Vemlidy to Treat Chronic Hepatitis B in Pediatric Patients

The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofivir alafenamide) 25 mg tablets by Gilead Sciences, Inc., to treat chronic hepatitis B virus (HBV) in pediatric patients older than 12 years with compensated liver disease. Vemlidy is a targeted, novel prodrug of tenofovir, which was previously […]

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European Commission Grants Orphan Medicinal Product Designation to Karyopharm and Menarini Group

The European Commission has granted Orphan Medicinal Product Designation to Karyopharm Therapeutics Inc., a pharmaceutical company pioneering cancer therapies, and Menarini Group, a leading international pharmaceutical company, for selinexor used to treat myelofibrosis (MF). Selinexor was granted the orphan drug designation by the US Food and Drug Administration (FDA) in May 2022. Selinexor is currently […]

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