On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously […]

As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year. Original and PAS Review   Review Time Goal Actions […]

3/22/2024 Pemgarda (220 KB) (reissued April 3, 2024 and August 26, 2024) Letter Granting EUA Amendment (May 17, 2024) (219 KB) Letter Granting EUA Amendment (September 26, 2024) […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-68 Product: Drugs Recipient: Recipient Name Mr. Roland Holmqvist Recipient Title Chief Executive Officer Rechon Life Science […]

Delivery Method: VIA UPS Reference #: 320-25-75 Product: Drugs Recipient: Recipient Name Daniel Ramirez, General Manager Recipient Title Dylan Kim, Vice President of R&D CTK OTC […]

Delivery Method: VIA UPS Reference #: 320-25-56 Product: Drugs Recipient: Recipient Name Mr. Ye Lin Chairman Recipient Title General Manager, and Owner Huangshi Hygienic Material Medicine […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-73 Product: Drugs Recipient: Recipient Name Alex Hua Recipient Title Sales Director Zhejiang Easyclean Daily Chemical Co., […]

Delivery Method: Via Email Product: DrugsFood & Beverages Recipient: Recipient Name Joan C. Ott Recipient Title Owner Mother Earth Minerals, Inc. 1260 S. 1200 W. Ste […]

Delivery Method: VIA UPS Reference #: 320-25-74 Product: Drugs Recipient: Recipient Name Mr. Luis E. Echeverria Recipient Title President Evi Labs LLC 9110 NW 106th StreetMedley, […]