Dec 2025 On December 16, 2025, the USFDA released updated guidance regarding ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved…
On Dec 11, 2025, the FDA announced a proposed order to add bemotrizinol (also known as Tinosorb S) to the OTC sunscreen…
Key Points: A new liquid infusion formulation of Remsima (infliximab) has been introduced in Europe as a 100 mg and 350 mg concentrate for…
What is TEMPO? On December 5, 2025, the FDA announced the TEMPO Pilot — formally: Technology-Enabled Meaningful Patient Outcomes for Digital Health…
1) What is Wiskott-Aldrich syndrome (WAS) and how it is caused WAS is an X-linked primary immunodeficiency that typically affects males and…
On November 13, 2025, the FDA approved Poherdy (pertuzumab-dpzb, by Shanghai Henlius Biologics Co., Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab,…
Introduction The guidance addresses how generic-drug applicants (via an Abbreviated New Drug Application, ANDA) may request a waiver under 21 CFR 314.99(b)…
1. Background on Elevidys 2. Trigger for Regulatory Action 3. Nature of the FDA Action (Labeling & Indication Revision) On November 14,…
Introduction The FDA’s guidance “How to Prepare a Pre-Request for Designation (Pre-RFD)” provides structured recommendations for sponsors seeking preliminary feedback from the…
