Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they told the agency the products were no longer marketed.
CDER lead consumer safety officer Leyla Rahjou-Esfandiary says the agency wants to receive comments by 11/22 on its proposal to increase the National ...
FDA warns seven dietary supplement manufacturers they are illegally selling products that claim to treat cardiovascular disease.
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...
