June 11, 2020

FDA approves nivolumab for esophageal squamous cell carcinoma

On June 10, 2020, the Food and Drug Administration approved nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell […]
June 11, 2020

Complex Innovative Trial Designs Pilot Program

On this page As displayed in the Federal Register notice on August 29, 2018, FDA is conducting a Complex Innovative Trial Design (CID) Pilot Meeting Program […]
June 10, 2020

Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error

Summary Company Announcement Date: September 12, 2019 FDA Publish Date: September 12, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Label mix-up Company Name: […]
June 9, 2020

organic-beauty-recipes.com – 607753 – 06/08/2020

Product: Drugs Date:               June 8, 2020 CC:                  [email protected] – Amazon Associates Program RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 […]
June 9, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 8, 2020

For Immediate Release: June 08, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 8, 2020

CURE ID App Lets Clinicians Report Novel Uses of Existing Drugs

CURE ID is an internet-based repository that lets the clinical community report novel uses of existing drugs for difficult-to-treat infectious diseases through a website, a smartphone […]
June 8, 2020

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Summary Company Announcement Date: October 30, 2018 FDA Publish Date: May 03, 2019 Product Type: DrugsPrescription Drugs Reason for Announcement: Recall Reason Description Due to detection […]
June 8, 2020

Innovation to Respond to COVID-19

Learn about FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible. FDA Efforts to Connect Manufacturers and Health Care Entities: The FDA, […]
June 8, 2020

Organic Herbal Supply Issues Voluntary Nationwide Recall Of All Lots Of Various Supplements For Male And Female Sexual Enhancement Due To Undeclared Active Ingredients

Summary Company Announcement Date: April 18, 2017 FDA Publish Date: February 08, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Active Ingredients tadalafil, […]
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