FDA Related News

Human Drugs

Fast Track for Surufatinib in Pancreatic Neuroendocrine Tumors

FDA grants Hutchison China MediTech two fast track designations for surufatinib for treating both advanced and progressive pancreatic neuroendocrine t...

Human Drugs

NIH, FDA Move on International Research Response

NIH, FDA, CDC and the European Medicines Agency aim to develop an international strategy for a coordinated research response to the Covid-19 pandemic.

Human Drugs

Seattle Genetics Tukysa OKd for Breast Cancer

FDA approves a Seattle Genetics NDA for Tukysa (tucatinib) for use in combination with chemotherapy for treating adult patients with advanced forms of...

Human Drugs

Judge Issues Restraining Order Against Covid-19 Product

A southern Florida federal judge enters an emergency temporary restraining order and a preliminary injunction against Genesis II Church of Health and ...

Human Drugs

Covid-19 Threatens Drug Evaluation Process: Researchers

Harvard Medical School researchers raise concerns about the risks in hastily allowing the use of unproven drugs to treat Covid-19.

Human Drugs

Covid-19 Emergency Compounding Guidance

FDA says it will not act against outsourcing facilities that take certain actions to compound drugs needed for hospitalized Covid-19 patients as long ...

Biologics

Recovered Covid Patients Should Donate Plasma: Hahn

FDA commissioner Stephen Hahn calls on recovered Covid-19 patients to donate blood plasma to be used in developing a convalescent plasma treatment to ...

Medical Devices

Device User Fee Reauthorization Meeting Postponed

FDA postpones a 5/5-planned public meeting entitled Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027.

FDA Maintaining User Fee Activities

FDA commissioner Stephen Hahn says the agency staff is keeping up with user fee review activities but may have to cut back due to Covid-19 activities.

Animal Drugs

CVM Goes After Unapproved Chloroquines

CVM warns two companies they are illegally distributing choloroquine phosphate products that are considered to be unapproved animal drugs.