Geography axis: coverage anchored in Latin America. Pair with exactly one subject category (Pharma, Policy & Markets, Digital Health, Medical Devices or a Therapy Area). Country, company and regulator go in tags.
ANS has added a PARP inhibitor for BRCA1/2-positive metastatic castration-resistant prostate cancer to Brazil’s mandatory private insurance coverage list, effective July 1, 2026, following public consultation.
ANVISA approved BridgeBio’s acoramidis on May 6 for ATTR-CM in an all-comers indication, citing ATTRibute-CM data showing 42% reduction in all-cause mortality and cardiovascular hospitalizations at 30 months.
Brazil’s MMA-Fiocruz partnership delivers the first Phyllanthus niruri phytotherapeutic for urinary disorders, anchoring a 2035 target of ten native-species drugs through ANVISA’s herbal pathway and SUS formulary integration.
Law 15.385/2026 mandates SUS incorporation of CONITEC-approved oncology drugs while a Fiocruz-MSD partnership delivers 100% domestically produced pembrolizumab, reducing Brazil’s import dependence for a flagship immunotherapy.
Mendoza becomes the first Argentine province to screen newborns for spinal muscular atrophy at birth, enabling pre-symptomatic treatment under a public-private accord with Novartis effective May 24, 2026.
ANS mandates private-plan coverage for olaparib in BRCA-mutant prostate cancer, osimertinib plus chemotherapy in EGFR+ lung cancer, and lebriquizumab in severe atopic dermatitis following a price concession.
ANVISA’s RDC 1023/2026 formalizes cannabis active pharmaceutical ingredient exports while the 8th Brazilian Pharmacopoeia edition sets new quality benchmarks, positioning Brazil’s industrial health complex for international market entry.
Brazil’s Ministry of Health and ONA have launched the country’s first accreditation manual for digital health, telemedicine, and telehealth services, establishing a formal quality and safety certification pathway for public …
ANVISA has approved serplulimab as the only anti-PD-1 authorized in Brazil for extensive-stage small cell lung cancer, giving Abbott a regulatory head start before larger checkpoint inhibitor rivals.
ANVISA’s approval of the 8th edition of Farmacopeia Brasileira updates national quality standards for medicines and active pharmaceutical ingredients, reshaping registration requirements across Brazil’s pharmaceutical market.
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