FDA Rejects Gilead’s Long-Acting HIV Drug Over Vial Issues
Summary : The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Gilead Sciences rejecting its New Drug Application…
Summary : The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Gilead Sciences rejecting its New Drug Application…
Summary : This week, Gilead Sciences took a $1.25 billion hit after reaching a settlement with ViiV Healthcare on a patent dispute…
Synopsis: The FDA granted orphan drug designation to GC012F, a novel chimeric antigen receptor T-cell therapy for the treatment of relapsed or…
SUMMARY: The U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive…
SYNOPSIS: VUMERITY is a next-generation oral fumarate treatment for people with relapsing-remitting MS with established efficacy and well-characterized safety, building on Biogen’s…
Keypoints: PTC Therapeutics, Inc. announced that the Brazilian National Health Surveillance Agency has approved the expansion of the indication of Translarna (Ataluren)…
Keypoints FDA Approves Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children Weighing at Least 14 kg. Biktarvy Provides an Effective Treatment…