Approval Date: 09-October-2026Regulatory Authority: U.S. Food and Drug Administration (USFDA)Applicant: AiCuris Anti-infective Cures AGApplication Type: New Drug Application (NDA 221154)Active Ingredient: PritelivirTherapeutic Area: Infectious Diseases | Antiviral Therapy The U.S.…
Date: 14-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has announced the Rare Disease Framework Initiative, aimed at developing a more flexible, consistent, and fit-for-purpose regulatory framework for…
Date: 13-Oct-2026 Inrelligence Overview The National Pharmaceutical Regulatory Agency (NPRA), Malaysia, published a safety alert on 13 October 2026 highlighting the potential risk of intestinal obstruction associated with glucagon-like peptide-1…
Date: 13-Oct-2026 INTELLIGENCE OVERVIEW The National Pharmaceutical Regulatory Agency (NPRA), Malaysia, has announced its year-end payment closure schedule for 2026. The temporary closure will affect payments made through the NPRA…
Date: 12-Oct-2026 The European Medicines Agency (EMA) has published a concept paper discussing the need to develop a dedicated guideline for the clinical investigation of medicinal products intended for the…
Date: 08-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has published the Study Data Technical Conformance Guide, a technical specifications document supporting the submission of standardized study data…
09-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has issued the guidance document “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers” in October 2026.…
09-Oct-2026 Intelligence OverviewThe U.S. Food and Drug Administration (USFDA) has issued the revised guidance document “Questions and Answers on Biosimilar Development and the BPCI Act (Revision 4)” in October 2026.…
23 September 2026 | U.S. FDA Regulatory Update The U.S. Food and Drug Administration (FDA) has approved Lirafugratinib (Lyrfigtu) capsules, developed by Elevar Therapeutics Inc., under NDA 220425. The approval…
Date: 21 September 2026 The U.S. FDA has updated its regulations to support the use of innovative alternatives to traditional animal testing in the development of human drugs and biological…