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…
Read more →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…
Read more →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…
Read more →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.…
Read more →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…
Read more →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…
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