Andelyn Biosciences is manufacturing Ultragenyx’s newly FDA-approved Fayuvi gene therapy [...]

The US Food and Drug Administration (FDA) has approved Mimrylo [...]

ViiV Healthcare has received US FDA approval for Tivicay PD [...]

The US FDA has approved Revolution Medicines’ daraxonrasib for adults [...]

The FDA has approved ViiV Healthcare’s Tivicay PD for children [...]

The FDA has accepted Belite Bio’s application for tinlarebant and [...]

The FDA has approved Moderna’s mRNA seasonal influenza vaccine mFLUSIVA [...]

The FDA has issued a Complete Response Letter for ITM-11, [...]

The US Food and Drug Administration (FDA) has approved Meitheal [...]

Tenpoint Therapeutics has submitted a Marketing Authorization Application (MAA) to [...]