-
FDA Approves Keytruda for First-Line Treatment of MSI-H/dMMR Colorectal Cancer
americanpharmaceuticalreview
July 09, 2020
The Food and Drug Administration (FDA) approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
-
Unichem Labs gets US FDA nod to market muscle spasm tablets
expresspharma
July 09, 2020
The product is a generic version of Janssen Research and Development LLC's Flexeril tablets.
-
FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems
fda
July 08, 2020
A summary of the FDA review of safety issues with the use of hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19 is now available.
-
FDA Updates and Press Announcements on NDMA in Metformin
fda
July 08, 2020
Today, the AAPS Journal, an official journal of the American Association of Pharmaceutical Scientists, published FDA’s manuscript entitled, “A Cautionary Tale: Quantitative LC-HRMS Analytical Procedures for the Analysis of N-Nitrosodimethylamine in Metfor
-
FDA Updates on Hand Sanitizers with Methanol
fda
July 08, 2020
FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination.
-
SARS-CoV-2 IgG Antibody Test Receives FDA Emergency Use Authorization
americanpharmaceuticalreview
July 08, 2020
Beckman Coulter announced its Access SARS-CoV-2 IgG assay has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA).
-
FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
europeanpharmaceuticalreview
July 08, 2020
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
-
FDA, EC Partner on COVID-19 Response
americanpharmaceuticalreview
July 07, 2020
The European Union (EU) is one of the U.S. Food and Drug Administration’s most important collaborators in tackling public heath challenges.
-
FDA Approves New Therapy for Dravet Syndrome
americanpharmaceuticalreview
July 07, 2020
The U.S. Food and Drug Administration (FDA) approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older.
-
FDA Approves New Therapy for Dravet Syndrome
americanpharmaceuticalreview
July 07, 2020
The U.S. Food and Drug Administration (FDA) approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older.