FDA Related News

Medical Devices

BD Recalls BD Alaris Pump Software

Becton Dickinson recalls (Class 1 device correction) its BD Alaris Pump Module Model 8100 with Guardrails, Suite MX software versions.

Human Drugs

Accelerated OK for Boehringer Lung Cancer Drug

FDA grants Boehringer Ingelheim accelerated approval for Hernexeos (zongertinib), a kinase inhibitor for treating certain adults with unresectable or ...

Human Drugs

FDA Ramps Up Global Drug Quality Oversight

FDA expands its drug quality enforcement efforts since the end of the Covid-19 Public Health Emergency, with foreign oversight reaching all-time highs...

Human Drugs

Valneva Chikungunya OK to Use Again: FDA

FDA lifts an earlier recommended pause on the use of Valnevas Ixchiq vaccine for chikungunya virus.

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...