Date: 20-Oct-2026Regulatory Authority: US Food and Drug Administration (USFDA)Applicant: GlaxoSmithKline LLCApplication Number: NDA 221276 The US Food and Drug Administration (USFDA) approved Hibsago (bepirovirsen) injection, developed by GlaxoSmithKline LLC, in…
Date: 19-Oct-2026Regulatory Authority: US Food and Drug Administration (USFDA)Applicant: Fresenius Medical Care Renal Therapies Group, LLC the US Food and Drug Administration (USFDA) approved two new drug applications (NDAs) submitted…
Publication date: 19-Oct-2026 Intelligence OverviewThe European Medicines Agency (EMA) has published a draft chapter of the Data Quality Framework (DQF) for EU medicines regulation, focusing on the collection, management and…
Date: 19-Oct-2026Agency: NPRA Malaysia Intelligence Overview Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 21 of 2026 requiring updates to the package inserts and Consumer Medication Information Leaflets…
Date: 19-Oct-2026Agency: NPRA Malaysia Intelligence Overview Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 20 of 2026 requiring the package inserts and Consumer Medication Information Leaflets (RiMUP) of…
Date: 21-Oct-2026 Agency: USFDA Intelligence Overview The U.S. Food and Drug Administration (USFDA) has issued the guidance document Regulatory Considerations for Prescription Drug Use-Related Software: Guidance for Industry. Developed collaboratively…
Date: 20-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA), through its Center for Drug Evaluation and Research (CDER), has issued the technical specifications document Submitting Clinical Trial Data…
Date: 19-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has revised its Small Entity Compliance Guide: Safety Reporting Requirements for INDs and BA/BE Studies in October 2026. The…
Date: 14-Oct-2026 The Saudi Food and Drug Authority (SFDA) has released its new Regulatory Guidance for Submissions and Applications (DS-G-144-V01/261014), taking effect on January 1, 2027. This framework replaces two…
Date: 16-Oct-2026 On 16 October 2026, the U.S. Food and Drug Administration (USFDA) approved BRYTLY (apraclonidine ophthalmic solution 0.125%), developed by Alcon Laboratories, Inc., as a nonprescription treatment for eye…