Image Español People who are pregnant or breastfeeding often need to take prescription medications. The use of prescription medication during pregnancy and while breastfeeding has increased […]

By: Cassandra L. Taylor, public health advisor, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Schuyler Pruyn, project manager, Office of […]

For Immediate Release: October 31, 2023 Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for […]

For Immediate Release: October 31, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, […]

Delivery Method: VIA UNITED PARCEL SERVICE Product: Drugs Recipient: Maria W. Greenwald, M.D. 72855 Fred Waring Drive, Suite A6Palm Desert, CA 92260-9369United States Issuing Office: Center […]

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Mr. Kenny S. Soejoto Recipient Title President/CEO ALI Pharmaceutical Manufacturing, LLC 4410 S. 102nd StreetOmaha, NE […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 24-HFD-45-10-01 Product: Drugs Recipient: Recipient Name Usama M. Abunadi Recipient Title President and CEO Samm […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Dilip Shanghvi Recipient Title Managing Director Sun Pharmaceutical Industries Ltd. Sun House, Plot No. 201 B/1Western […]

Accelerating Anticancer Agent Development and Validation Workshop (AAADV) | FDA In this section: News & Events for Human Drugs Home Drugs News & Events for Human […]