News

FDA Approves Treatment for Chronic Kidney Disease

Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and…

FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose

The U.S. Food and Drug Administration announced today the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly…

FDA Commits to Evidence-Based Actions  Aimed at Saving Lives and Preventing Future Generations of Smokers

Today, the U.S. Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using…

La FDA se compromete a tomar medidas basadas en la evidencia dirigidas a salvar vidas y prevenir futuras generaciones de fumadores

Hoy, la Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) anunció que se compromete a avanzar en el desarrollo…

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov

Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and…

Coronavirus (COVID-19) Update: April 27, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the…

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S….

Coronavirus (COVID-19) Update: April 23, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the…

FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to…

FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed…