A USFDA Warning Letter (WL) is the single most serious regulatory escalation a USFDA-regulated company can receive, confirming significant violations of the Federal Food, Drug, and Cosmetic (FD&C) Act, most often related to Current Good Manufacturing Practice (CGMP). Unlike a…
HYRNUO® (sevabertinib), a reversible tyrosine kinase inhibitor targeting HER2 (ERBB2), received FDA approval on November 19, 2025, under the accelerated approval pathway for a molecularly defined population of lung cancer patients [Approval Letter, November 19, 2025, Reference ID: 5698585]. This approval…
The U.S. Food and Drug Administration (FDA) approved Grafapex treosulfan on January 22, 2025, marking a significant advancement in preparative regimens for allogeneic hematopoietic stem cell transplantation (alloHSCT) in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) 310. Developed by Medac GmbH and…
When you’re eyeing a pharma company, understanding its market value is a crucial first step. Knowing how to assess a pharma unit before forwarding towards a deal is most crucial. It’s not just about the asking price—there’s a lot more…