SAHPRA SAPC regulatory enforcement has intensified following the seizure of all GLP-1 and GIP injectable products at iDexis (Pty) Ltd trading as Sentra Pharmacy. An inspection on 11 May 2026 revealed the facility was manufacturing and distributing unregistered medicines containing semaglutide, ti...

MDR software regulations under the EU’s Medical Device Regulation (EU 2017/745) are creating heavy operational and financial pressures, according to a survey of 35 SaMD manufacturers listed in the EUDAMED database. Financial burdens hit 88.6 % of respondents at significant or severe levels, while...

Bial announced the completion of the treatment period in its Phase 2b ACTIVATE study evaluating BIA 28-6156 (pariceract) in patients with Parkinson’s disease (PD) who carry a pathogenic mutation in the glucocerebrosidase 1 (GBA1) gene, referred to as GBA-PD. The 78-week double-blind treatment pha...

An analysis of 1.2 million days of data from 2,596 women across 42,759 menstrual cycles demonstrates that cycle length strongly influences the magnitude of fluctuations in cardiorespiratory biometrics, while shorter sleep durations correlate with greater cycle length deviation. Resting heart rate...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of KEYTRUDA (pembrolizumab), including its subcutaneous formulation KEYTRUDA SC, combined with Padcev (enfortumab vedotin-ejfv) as neoadjuvant treatment followed b...

The rapid evolution of AI Healthcare Policy is evident in the Health & AI Policy Index (HAPI) snapshot from January 1, 2026, which catalogs 240 policies illustrating swift expansion of artificial intelligence governance across U...