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: BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VOXZOGO™ (Vosoritide) for Injection, indicated…
Keypoints FDA Approves Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children Weighing at Least 14 kg. Biktarvy Provides an Effective Treatment…