FDA approves Lillys Rezvoglar as the second interchangeable biosimilar insulin product.
Nine Democratic senators ask FDA to take three steps to protect and expand access to medication abortions.
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.
