Hologic Granted FDA Emergency Use Authorization for Its Second Molecular Test for COVID-19

Significant Test Manufacturing Capacity, Large Installed Base of Automated Instruments Yield Testing Breakthrough MARLBOROUGH, MA (STL.News)…

FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options THOUSAND OAKS, CA…

FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products

FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market…

Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision

Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs…

FDA on Signing of the COVID-19 Emergency Relief Bill

FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User…

US Food and Drug Administration Approves ZEPOSIA for Multiple Sclerosis

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for…

FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing

WALTHAM, MA (STL.News) PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier…

Abbott Receives FDA Emergency Use of Authorization & Launches Test for Coronavirus

– The test will be used on the company’s m2000 RealTime system that is currently available…

Kettle Cuisine Midco, LLC, Recalls Ready-To-Eat Soup Products due to Misbranding and Undeclared Allergens

WASHINGTON, DC (STL.News) Kettle Cuisine Midco, LLC, a Lynn, Mass. establishment, is recalling approximately 200 pounds…

FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity

Silver Spring, MD (STL.News) The U.S. Food and Drug Administration is alerting health care professionals and…

FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration is alerting health care professionals…

FDA Statement on continued efforts to increase availability of naloxone to help reduce opioid overdose deaths

Silver Spring, MD (STL.News) – Addressing opioid overdose continues to be one of the most urgent…

Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products

FDA compliance policy would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes SILVER SPRING, MD…

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

Silver Spring, MD (STL.News) – Monday, the U.S. Food and Drug Administration announced that an emergency…

FDA approves new device to improve symptoms in patients with advanced heart failure

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration today approved the Barostim Neo…