On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with […]

2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) | FDA In this section: Obstetrics, Reproductive and […]

Q1. What is isotretinoin?  A1. Isotretinoin is a prescription medicine approved for use in patients 12 years of age and older, who are not pregnant, for the […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name John Howell Recipient Title Executive Vice President Boothwyn Pharmacy, LLC 221 Gale LaneKennett Square, PA 19348United […]

Delivery Method: VIA UPS Reference #: 320-26-42 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Yanzhuan Zheng Recipient Title Owner/President Bio-Medical Pharmaceutical Manufacturing Corporation 4311 South […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name James Nabors III Recipient Title Manager Beach Weekend Management LLC dba Nic and Jet Fuel 119 Hollywood […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-02-01 Product: Drugs Recipient: Mark S. Dacey, M.D. 425 South Cherry Street, Suite 907Denver, CO […]

Delivery Method: VIA UPS Reference #: 320-26-38 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Ms. Maria Esparza Recipient Title President and Owner Signature Formulations, LLC 5446 […]

The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil […]