On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab […]

Docket Number: FDA-2017-D-6821 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research As part […]

On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-01-01 Product: Drugs Recipient: Americo F. Padilla, M.D. 8955 Southwest 87th Court, Suite 110Miami, FL […]

What is the RDRC Program? The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-02-01 Product: Drugs Recipient: Recipient Name Jack Oswald Recipient Title CEO ISOThrive, Inc. 2165 Toyon […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-40 Product: Drugs Recipient: Recipient Name Ren Zhongju Chengdu Innovation Pharmaceutical Co., Ltd. No.123, 1st Floor, No 91 Zhongheng […]

Delivery Method: Via Electronic Mail Return Confirmation Requested Reference #: 320-25-38 Product: Drugs Recipient: Recipient Name Ms. Hongwei Xu Recipient Title General Manager Wuhu Nuowei Chemistry […]

Delivery Method: Via Electronic Mail Return Confirmation Requested Reference #: 320-25-37 Product: Drugs Recipient: Recipient Name Mr. Sudheer Kancherla Recipient Title Chief Executive Officer Strukmyer LLC […]