FDA: Coronavirus (COVID-19) Update: Daily Roundup, March 24, 2020
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
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FDA: Coronavirus (COVID-19) Update: Daily Roundup, March 25, 2020
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
FDA: Coronavirus (COVID-19) Update: Daily Roundup March 26, 2020
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
FDA: Coronavirus (COVID-19) Update: Daily Roundup March 27, 2020
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
FDA: Insulin Gains New Pathway to Increased Competition
A historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.
FDA: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
The U.S. Food and Drug Administration took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturersExternal Link Disclaimer importing personal protective equipment and other devices.
EIGER BIOPHARMACEUTICALS: Completes Submission of New Drug Application to FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies
Progeria MAA Submitted to EMA and Granted Accelerated Assessment
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.
VERO BIOTECH: Announces First Patient With COVID-19 Infection Complicating Pulmonary Hypertension Treated with GENOSYL® DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide
Treatment informs FDA approval for emergency expanded access use for GENOSYL® inhaled nitric oxide
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.