Summary : The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to…
Summary : This week, Gilead Sciences took a $1.25 billion hit after reaching a settlement…
US FDA Grants Orphan Drug Designation to Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy, GC012F to Treat Multiple Myeloma.
Synopsis: The FDA granted orphan drug designation to GC012F, a novel chimeric antigen receptor T-cell…
SUMMARY: The U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive…
The European Commission Grants Marketing Authorization for VUMERITY® (Diroximel Fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis.
SYNOPSIS: VUMERITY is a next-generation oral fumarate treatment for people with relapsing-remitting MS with established…
Active Pharmaceutical Ingredients (API)Ataluren
ANVISA grants expanded Approval to PTC’s Translarna label to include Ambulatory Patients as young as 2 years old in Brazil.
Keypoints: PTC Therapeutics, Inc. announced that the Brazilian National Health Surveillance Agency has approved the…
Active Pharmaceutical Ingredients (API)BictegravirEmtricitabineTenofovir Alafenamide
USFDA Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations
Keypoints FDA Approves Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children Weighing at Least…