FDA Related News

Human Drugs

Appeals Court Upholds Norwich ANDA Delay

A federal appeals court affirms a lower court decision barring FDA from approving a Norwich ANDA for a generic form of Salix Xifaxan until 10/2/2029.

Human Drugs

FDA Complex Innovative Designs Meeting Praised

Two stakeholders comment positively on an FDA public meeting on advancing the use of complex innovative designs in clinical trials.

Human Drugs

FDA OKs CAR-T Trial in Children for Lupus

FDA authorizes Seattle Childrens Therapeutics to launch a CAR T-cell trial to treat lupus in children.

Medical Devices

Army Scientific Groups Hemorrhage AI Detector Cleared

FDA clears a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intelligence-powered smartpho...

Human Drugs

Lisata Orphan Status for Osteosarcoma Drug

FDA grants Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma.

Federal Register

Italfarmaco Awarded Priority Review Voucher

Federal Register notice: FDA issues a priority review voucher to Italfarmaco SpA for being the sponsor of a rare pediatric disease product application...

Human Drugs

Par Sues FDA Over BPI Epinephrine Approval

Par Pharmaceutical asks a court to stop FDA from granting final approval to a BPI epinephrine product that cites a Par product as the reference-listed...

Human Drugs

ODAC to Discuss Minimal Residual Disease Endpoint

FDA asks the Oncologic Drugs Advisory Committee to consider whether minimal residual disease is an appropriate intermediate clinical endpoint to suppo...

Include Pregnant, Lactating Women in Trials: Report

A new National Academies report calls on FDA and other federal government entities to take steps to increase the participation of pregnant and lactati...

Medical Devices

Import Alert Against China Syringe Maker

In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency issues an import alert against Jiangsu S...