Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER recent refusal to approve a Vanda supplemental NDA for Hetlioz (tasimelteon).
Johnson & Johnson stops its Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder due to a lack of sufficient efficacy data.
Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER recent refusal to approve a Vanda supplemental NDA for Hetlioz (tasimelteon).
Johnson & Johnson stops its Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder due to a lack of sufficient efficacy data.
Consultants from Eliquent Life Sciences say most of FDA’s drug inspection-based Warning Letters issued in fiscal year 2024 went to domestic firms, although the percentage of international firms being inspected increased.
FDA approves a Celltrion BLA for Omlyclo, the first interchangeable biosimilar to Genentech’s Xolair (omalizumab).
