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Last updated 1 day ago
BAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE INFUSION BAG IN 100ML DUE TO PARTICULATE MATTER FOUND IN SOLUTION
1 day ago
July 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily...
FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
1 day ago
On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro...
CDER Nitrosamine Impurity Acceptable Intake Limits
2 days ago
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated Information
Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter
2 days ago
July 24, 2026 - Taoyuan City, Taiwan - Sunny Pharmtech, Inc is...
FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief
2 days ago
On July 24, FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium...
New Approach Methodologies (NAMs)
2 days ago
The FDA is leading a transformative shift in drug safety evaluation—reducing, replacing...
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products
2 days ago
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products
Monoclonal Antibodies: Streamlined Nonclinical Safety Studies
2 days ago
The Food and Drug Administration (FDA or Agency) is announcing the availability...
General Considerations for the Use of New Approach Methodologies in Drug Development
2 days ago
This draft guidance provides drug developers with a validation framework and general...
Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop - 05/18/2026
2 days ago
FDA is convening a one-day virtual public workshop on May 18, 2026...
New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
3 days ago
Discover potential signals of serious risks and new safety information identified by...