In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across…
Tag: FDA
FDA Warning – Pain and Fever Medication – Pregnancy Complications
FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy…
Pfizer and BionTech Granted FDA Fast Tract Designation
Pfizer and BionTech Granted FDA Fast Tract Designation for two Investigational MRNA-Based Vaccine Candidates Against SARS-COV-2…
Abbott receives FDA approval for new heart rhythm devices
Abbott receives FDA approval for new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring…
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…