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Last updated 1 day ago
Study Data Technical Conformance Guide - Technical Specifications Document
1 day ago
This technical specifications document represents the Food and Drug Administration's (FDA's) current...
FDA Approves Drug for Pediatric Stage 3 Type I Diabetes
1 day ago
The U.S. Food and Drug Administration (FDA) has approved Tzield (teplizumab) injection...
FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
1 day ago
On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap...
Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research
1 day ago
As part of the reauthorization of the Prescription Drug User Fee Act...
Real-World Evidence Submissions to the Center for Drug Evaluation and Research
1 day ago
As part of the reauthorization of the Prescription Drug User Fee Act...
Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination
1 day ago
FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals...
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
1 day ago
FDA does not issue approval announcements for every approval or drug label...
FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
1 day ago
On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg...
January - March 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
1 day ago
January - March 2022 | New Safety Information or Potential Signals of...
July - September 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
1 day ago
July - September 2022 | New Safety Information or Potential Signals of...
October - December 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
1 day ago
New Safety Information or Potential Signals of Serious Risks Identified from the...
April - June 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
1 day ago
April - June 2022 | New Safety Information or Potential Signals of...