6th August 2026 - FDA Tentative Approval for Omcazio: A New Cabozantinib Capsule Formulation Handa Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to Omcazio (cabozantinib) capsules, a novel alternate-salt formulation of the well-established tyrosine kinase inhibitor (TKI). Developed under the Section 505(b)(2) regulatory pathway, Omcazio represents a pharmacological evolution of cabozantinib. Unlike current formulations, this capsule is engineered to improve drug absorption and has demonstrated no clinically significant food effect in bioavailability studies. While a tentative approval indicates the product meets all safety, effectiveness, and manufacturing quality standards, the drug is not yet available…