A curated library of guides, compliance knowledge, and operational insights to help pharmaceutical teams navigate Open Payments reporting, manage HCP events, and streamline field workflows.
Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop.Read more
On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBBRead more
Bayer has won first-line approval for its tyrosine kinase inhibitor, Hyrnuo, in patients with HER2-mutant non-small cell lung cancer. The green light comes around half a year after a similar nod for rival TKI med Hernexeos from Boehringer Ingelheim.Read more
On October 16, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA (Foundation), will convene a hybrid meeting to explore the patient voice in rare disease medical product development (biologic, drug, and device).Read more
