FDA Related News

Human Drugs

Fast Track for Krystal Biotech Topical Drug

FDA grants Krystal Biotech a fast track designation for KB103 for treating dystrophic epidermolysis bullosa.

Human Drugs

Pfizer Gains Breakthrough Status for Rare Disease Drug

FDA grants Pfizer a breakthrough therapy designation for tafamidis for treating patients with transthyretin cardiomyopathy, a rare and fatal condition...

Human Drugs

Acel Rx Resubmits NDA for Pain Drug

FDA accepts for review an AcelRx Pharmaceuticals NDA resubmission for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-se...

Biologics

Bio Products sBLA Accepted for Coagadex

FDA accepts for review a Bio Products Laboratory supplemental BLA for Coagadex (coagulation factor X, human) for prophylactic treatment of hereditary ...

Human Drugs

SCOTUS Wont Hear Appeal of Solvay Off-Label Case

Two Hyman, Phelps attorneys say the Supreme Court has declined to hear awhistleblowers appeal of a 5th Circuit Court of Appeals decision in a Solvay P...

Human Drugs

FDA Rejects NDA for Recro Meloxicam

FDA issues a complete response letter to Recro Pharma for its IV meloxicam NDA.

Human Drugs

Pfizer Settles False Claims Case for $23 Million

Pfizer settles a False Claims Act case involving kickbacks for three of its drugs for $23.85 million.

Senate Gives FDA $159 Million Boost, 50% Less Than House

A Senate Appropriations Committee approves $2.97 billion in discretionary funding for FDA, which is $159 million (5%) over the FY 2018 enacted level, ...

Medical Devices

FDA Clears Mauna Kea Cellvizio 100 Neurosurgical Laser

FDA clears a Mauna Kea Technologies 510(k) for the Cellvizio 100 series F400 and F800 multidisciplinary confocal laser endomicroscopy platform for use...

Federal Register

Guide on Anthrax Prevention Drugs

Federal Register notice: FDA makes available a guidance entitled Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.