Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid…
Screening and Quantification of the Synthetic Cannabinoid Receptor Agonist 5F‐MDMB‐PINACA From Seized Prison Paper Using Ultraperformance Liquid Chromatography–Mass Spectrometry Approaches
Synthetic cannabinoid receptor agonists are being infused on paper and illicitly introduced into prisons through mail correspondence. An approach to…
Fentanyl and Propofol Misuse: Hair Analysis Provides Significant Evidence in the Death of a Young Doctor
This article describes a postmortem case of a doctor in the context of polydrug use. A potentially lethal level of…
FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS
On Jan. 21, 2025, the FDA approved treosulfan (Grafapex, medac GmbH) with fludarabine as a preparative regimen for allogeneic hematopoietic…
FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer
On January 27, 2025, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive,…
Biosimilar Product Information
This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access…
Novel Drug Approvals for 2025
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
Novel Drug Approvals at FDA
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center…
Orange Book Preface
Preface to Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) provides info on how the book came to be,…