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...

Human Drugs

FDA Acting Against Unapproved Thyroid Meds

FDA says it will allow up to 12 months for doctors to transition patients who are taking unapproved animal-derived thyroid medications to approved syn...

Human Drugs

Lilly Plans NDA for Oral Weight-Loss Drug

Eli Lilly says it will file an NDA by the end of the year for its investigational obesity treatment orforglipron, based on just-announced Phase 3 data...

Medical Devices

Alert on Boston Scientific Defibrillation Leads

FDA issues an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads that may impact shock e...

Medical Devices

FDA Early Alert on Watchman Devices

FDA issues an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use instructions to preve...