Tuesday, April 7, 2020

Tuesday, April 7, 2020

Latest News

LUMINEX: Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease

Luminex is now able to provide SARS-CoV-2 diagnostic tests for both high-complexity, high-throughput reference labs and moderate complexity, sample-to-answer testing facilities

PERRIGO: Announces FDA Approval for the Store Brand Equivalent of Voltaren® Arthritis Pain

Perrigo Company plc (NYSE: PRGO; TASE) announced that it was the first to receive approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA)

JAZZ PHARMACEUTICALS: Announces FDA Acceptance of New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the company's New Drug Application (NDA) seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

AMPIO PHARMACEUTICALS, INC.: Ampio is Preparing an Expanded Access FDA protocol to Study Nebulized Ampion as a Treatment for Moderate to Severe Acute Respiratory Distress Syndrome Associated with COVID-19

Ampio Pharmaceuticals, Inc. issued the following announcement on March 24.Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions for which limited treatment options exist, announced today that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2 ("COVID-19") induced Acute Respiratory Distress Syndrome ("ARDS"), an immediately life-threatening condition.Ampio's Scientific Advisory Board ("SAB") members David Bar-Or, MD, Pablo Rubinstein, MD, and Edward Brody, MD, PhD, determined after a careful review of the published articles on the properties of Ampion, that nebulized Ampion may be suitable to treat another inflammatory indication.

FDA Health News