FDA approves first drug to treat serious complication of stem cell transplant
The U.S. Food and Drug Administration (FDA) approved Yartemlea (narsoplimab-wuug) injection to treat adults and children 2 years and older…
FDA approves first oral treatment for anemia in thalassemia, an inherited blood disorder
The U.S. Food and Drug Administration (FDA) approved Aqvesme (mitapivat) tablets to treat anemia (low levels of red blood cells)…
July – September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
July – September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System…
Drug Trials Snapshots: VIZZ
Drug Trials Snapshots: VIZZ
Drug Trials Snapshots: LYNKUET
Drug Trials Snapshots: LYNKUET
Advanced Manufacturing Technologies Designation Program
FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing…
Private Label Skin Care, Inc. – 715880 – 12/18/2025
CGMP/OTC/Adulterated/Misbranded
Devalingam Mahalingam, M.D., Ph.D. – 721145 – 12/11/2025
Clinical Investigator
Unipack LLC – 716621 – 12/19/2025
CGMP/Finished Pharmaceuticals/Adulterated
Agebox Inc. – 718252 – 12/19/2025
Unapproved New Drug/Misbranded