Regulatory policy, compliance, approvals, enforcement
Mercado Livre launched prescription medicine sales in São Paulo on 25 September 2026, including GLP-1 drugs and antibiotics, as pharmacy chain shares fell sharply and Abrafarma said it would formally …
The European Commission has approved obicetrapib, as Ubeslo and as Evlarco (with ezetimibe), for adults with primary hypercholesterolaemia or mixed dyslipidaemia — what the companies call a first-in-class approval for …
The FDA approved rebisufligene etisparvovec (Fayuvi) on September 17, 2026 — the first therapy cleared to alter the course of Sanfilippo syndrome type A in pediatric patients, giving Ultragenyx its …
Argentina’s ANMAT preventively halted all production and sales by Trifarma S.R.L. and Ugal Farmacéutica S.A. and prohibited all their products nationwide, citing technical director and quality control deficiencies.
Mexico’s Cofepris has granted marketing authorization for lenacapavir as twice-yearly injectable pre-exposure prophylaxis against HIV, placing Mexico among a small group of countries with regulatory access to the long-acting prevention …
The first new-class painkiller in decades has near-universal US coverage and negligible sales — and no clear path to Latin American patients.
Same bet, opposite outcomes: Rede D’Or’s insurer-hospital machine compounds while Hapvida’s verticalization buckles under claims, losses and member cuts.
Colombia’s highest administrative court suspended Decree 0182 on May 4, 2026, freezing a territorial restructuring of health insurers that would have forcibly reassigned an estimated 6.6 million affiliates.
AbbVie has completed its $10.9 billion acquisition of Apogee Therapeutics, adding zumilokibart — a long-acting interleukin-13 antibody positioned against Dupixent — to its immunology portfolio.
Colombia’s Ministry of Health declared public interest grounds to pursue mandatory licensing of Gilead’s sofosbuvir-based hepatitis C patents, transferring the process to the competition authority for a final determination.
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