Members of the FDA Cardiovascular and Renal Drugs Advisory Committee vote to recommend approval of Ardelyx tenapanor for a kidney disease indication. ...
Pfizer and BioNTech begin a Phase 1 study of their next-generation Covid-19 vaccine that they say is designed to enhance SARS-CoV-2 T cell responses a...
FDA Oncology Center of Excellence director Richard Pazdur says data from multiregional trials that represent the major International Conference for Ha...
FDA commissioner Robert Califf and Oncology Center of Excellence director Richard Pazdur endorse a return of FDA employees to the White Oak, MD headqu...
An Insulet recall of its Omnipod DASH Insulin Management System receives a Class 1 recall classification by FDA.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for use by ANDA sponsors.
Two FDA information technology executives describe the agencys new cybersecurity modernization action plan.
Federal Register notice: FDA announces its preliminary assessment that certain types of naloxone hydrochloride drug products may be approvable as safe...
