An official from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science (OPS) provided a presentation on the state of the proposed Generic Drug User Fee Act(GDUFA), which ...

Celltrion has obtained the Food and Drug Administration’s clearance for a new presentation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), in a 45mg/0.5ml solution in a ...

A new draft guidance document published by the US Food and Drug Administration (FDA) is aimed at clarifying which information should be included in an investigational device exemption (IDE) ...

The new prefilled syringe has the same composition but removes the need for reconstitution. The Food and Drug Administration (FDA) has accepted for review the regulatory application for a new ...

GSK has received the Food and Drug Administration’s approval for a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster).

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule)[1] to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) ...