Product: Drugs Recipient: IceRx United States Issuing Office: Center for Drug Evaluation and Research 10903 New Hampshire AvenueSilver Spring, MD 20993United States The United States (U.S.) […]

FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer On May 31, 2023, the Food and Drug Administration approved olaparib […]

Delivery Method: Via Email Reference #: FEI 3003677831 Product: Drugs Recipient: Recipient Name Mr. Dinkar K. Raut Recipient Title Managing Director Keshava Organics Private Ltd. T-97, […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Dr. Robert Higgins Recipient Title President and CEO Brigham and […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Sunil Eppen, MD Recipient Title Interim President and Chief Medical Officer Brigham and Women’s Hospital Inc. […]

Drug  Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abametapir – Xeglyze HATCHTECH PTY LTD Medical (PDF – 4 MB) Addendum (PDF […]

Today, FDA issued the Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Final Guidance for Industry. This final guidance describes the agency’s […]

Summary Company Announcement Date: August 25, 2020 FDA Publish Date: August 25, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol […]

Summary Company Announcement Date: August 18, 2020 FDA Publish Date: August 18, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Methanol […]