December 5, 2020

WishGarden Herbs Issues Voluntary Nationwide Recall of Cord Care and Goldenseal Powder Due to Bacterial Contamination

Summary Company Announcement Date: December 04, 2020 FDA Publish Date: December 04, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product may be contaminated […]
December 4, 2020

FDA approves weight management drug for patients aged 12 and older

[12/4/2020] The U.S. Food and Drug Administration has approved Saxenda (liraglutide) for chronic weight management among patients aged 12 and older who are obese, as defined […]
December 4, 2020

New studies show diabetes drug not proven to improve blood sugar control in pediatric patients

[12/4/2020] The U.S. Food and Drug Administration has approved labeling changes stating that Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metformin […]
December 4, 2020

Antiseptic FDA Letters

Consumer hand rub antiseptics granted deferral letter October 31, 2017: FDA issued deferral grant letters requesting that ethyl alcohol, isopropyl alcohol, and benzalkonium chloride be deferred […]
December 4, 2020

Remarks by Dr. Hahn to the Remarks to the National Academy of Medicine Town Hall on the COVID-19 Vaccine – 12/04/2020

Thank you for being here today for this important conversation, and to be sharing the computer screen with our colleagues under the HHS umbrella, all of […]
December 4, 2020

Drug Trials Snapshots: ZOKINVY

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
December 4, 2020

Understanding the Silent Killer

The Who, What, Why, and How of High Blood Pressure  Who is affected by high blood pressure? Approximately 1 in 3, nearly 70 million, American adults […]
December 3, 2020

Coronavirus (COVID-19) Update: December 3, 2020

For Immediate Release: December 03, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
December 3, 2020

BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Over the years, FDA has worked to increase communication between Agency staff and applicants during the review of novel drug and original biologic applications. The goal […]
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