ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
Dec 2025 On December 16, 2025, the USFDA released updated guidance regarding ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs. This guidance is a revision (Revision 2) of the agency’s current thinking on how generic drug applicants should manage amendments to their Abbreviated New Drug Applications (ANDAs). Key Highlights of the December […]
Wiskott-Aldrich syndrome (WAS) — disease overview, therapies, and what Waskyra changes
1) What is Wiskott-Aldrich syndrome (WAS) and how it is caused WAS is an X-linked primary immunodeficiency that typically affects males and is caused by mutations in the WAS gene, which encodes the Wiskott-Aldrich syndrome protein (WASp). WASp is expressed in hematopoietic cells and is essential for reorganization of the actin cytoskeleton during immune-cell activation, […]
FDA Approves First Interchangeable Biosimilar to Perjeta (pertuzumab) Genentech
On November 13, 2025, the FDA approved Poherdy (pertuzumab-dpzb, by Shanghai Henlius Biologics Co., Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, by Genentech Inc.). U.S. Food and Drug Administration This marks the first biosimilar approved for Perjeta. U.S. Food and Drug Administration Indications for Poherdy include: The approval rests on comprehensive data comparing product […]
Elevidys Gene Therapy Under Stricter FDA Controls After Fatal Liver Injury Reports
1. Background on Elevidys 2. Trigger for Regulatory Action 3. Nature of the FDA Action (Labeling & Indication Revision) On November 14, 2025, the FDA approved revised labeling for Elevidys. Key components: 3.1 Boxed Warning 3.2 Indication Limitation 3.3 Updates to Other Labeling Sections 3.4 Monitoring and Risk-Mitigation Measures The revised labeling mandates specific monitoring […]