FDA Proposal to Add Bemotrizinol to Sunscreen Monograph
On Dec 11, 2025, the FDA announced a proposed order to add bemotrizinol (also known as Tinosorb S) to the OTC sunscreen monographfda.gov. This proposal – the first new sunscreen active ingredient in decades – is intended to modernize U.S. sunscreen regulation and expand broad-spectrum options. In FDA’s review, bemotrizinol “provides protection against both ultraviolet […]
Safety Update: New Sorbitol-Containing IV Remsima Formulation
Key Points: A new liquid infusion formulation of Remsima (infliximab) has been introduced in Europe as a 100 mg and 350 mg concentrate for infusion. Unlike the original powder form, the new concentrate contains sorbitol (45 mg/mL)ema.europa.eu. Because patients with hereditary fructose intolerance (HFI) cannot safely metabolize sorbitol, this formulation must not be given to HFI patientsema.europa.eu. Even […]
TEMPO – The Digital Health Pilot by FDA
What is TEMPO? On December 5, 2025, the FDA announced the TEMPO Pilot — formally: Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot. U.S. Food and Drug Administration In other words, TEMPO does not represent a loosening of standards per se, but rather a new, risk-based regulatory approach designed specifically to accelerate adoption of […]
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 […]
Unlocking Flexibility: FDA’s 2025 Guidance on pH Adjuster Waivers for Complex Generics
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) of the requirement in 21 CFR 314.94(a)(9)(iii) and (iv) that inactive ingredients (specifically pH adjusters) in a generic product be qualitatively (Q1) and quantitatively (Q2) the same as the Reference Listed Drug (RLD), […]
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 […]
How to Prepare a Pre-Request for Designation (Pre-RFD)
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 Office of Combination Products (OCP) on how their product should be classified (drug, device, biologic, or combination product) and to which FDA centre (e.g.,Although this is a U.S. FDA document, its lessons and […]
Depth Article: Revisiting Hormone Replacement Therapy — A Paradigm Shift in Women’s Health
1. Background: What Changed The U.S. Food & Drug Administration (FDA), in coordination with the U.S. Department of Health & Human Services (HHS), has announced a significant regulatory reconsideration: the move to remove or revise longstanding boxed-(“black box”) warnings on many hormone replacement therapies (HRT) for menopause. U.S. Food and Drug Administration+2Science News+2These warnings have […]