FDA Related News

Human Drugs

FDA Steps to Boost U.S. Drug Production

FDA says it is starting the FDA PreCheck program to help drug companies develop manufacturing facilities in the U.S.

Human Drugs

FibroGen, FDA Agree on Roxadustat Phase 3 Elements

FDA and FibroGen reach an agreement on key elements in a Phase 3 trial of the companys roxadustat to treat some chemotherapy-induced anemias.

Human Drugs

ICH Extractables, Leachables Guide

FDA publishes a draft International Council on Harmonization guideline for extractables and leachables to solicit public comment.

Julie Tierney Joins Leavitt Partners

Former FDAer Julie Tierney is now a principal in Leavitt Partners Washington office.

Human Drugs

J&J Complete Response Letter on Darzalex Faspro

FDA issues Johnson & Johnson a complete response letter for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in a quadrup...

Medical Devices

Instylla PMA Approved for Hypervascular Tumors

FDA approves an Instylla PMA for its Embrace Hydrogel Embolic System, a liquid embolic device for treating hypervascular tumors in peripheral arteries...

Medical Devices

QS, MDR Issues at Taiwans Visgeneer

FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood glucose and blood uric a...

Medical Devices

Medical Device PFAS Appear Safe: FDA

FDA issues an online post describing the safety to patients of the type of PFAS used in medical devices.

Medical Devices

BMS Files Breyanzi Marginal Zone Lymphoma sBLA

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for...

Human Drugs

Lantheus NDA for Pylarify New Formulation

FDA accepts a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen imaging agent.