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FDA General

Science Board to Review Cure Act Work Plan

FDA asks its Science Board for comments on a draft work plan on 21st Century Cures Act Innovation Account Activities that prioritizes patient-focused ...

Human Drugs

Drug Spending Ebbed Last Year: Report

Growth in U.S. spending on prescription drugs drops as competition between manufacturers heats up and payers step up efforts to curb price increases, ...

Human Drugs

FDA Approves Mitsubishi Drug for Lou Gehrigs Disease

FDA approves a Mitsubishi Tanabe Pharma America NDA for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly known as L...

FDA General

FDA Denies Claims Its Staff May Watch Only Fox News

Media reports indicate the Trump Administration wants Fox News broadcasts to replace CNN on internal video monitors across FDAs White Oak, MD campus, ...

Human Drugs

Dr. Reddys Form 483 Posted on Bachupally, India Inspection

FDA posts a Dr. Reddys Laboratories Form 483 from a 4/28 inspection that cited the firms Bachupally, Hyderabad, India manufacturing facility on 11 obs...

Human Drugs

Appeals Court Remands Elements of Clomid Case

The 10th Circuit Appeals Court tells a Utah federal court to reconsider portions of a case brought by a couple alleging that their son was born with b...

Medical Devices

FDA Approves Cardiovascular Systems Replacement Saline Pump

FDA approves a Cardiovascular Systems PMA supplement for a redesigned saline pump used as part of its Diamondback 360 Orbital Atherectomy Systems.

Human Drugs

Fast Track Given to Alto Bio Bladder Cancer Therapy

FDA grants Altor BioScience a fast track designation for its investigational interleukin-15 agonist complex, ALT-803, in combination with bacillus Cal...

Human Drugs

Biosimilars Forum Seeks Flexible Interchangeability Approach

The Biosimilars Forum urges FDA to be more flexible with its approach in determining a proposed biosimilar products interchangeability with an innovat...

Human Drugs

Wockhardt Grappling with FDA Issues

Wockhardt says expenses to correct issues raised by FDA at several of its facilities adversely affected company profitability in the first quarter.