HealthSignals coverage organized by therapeutic area: oncology, cardio-metabolic disease, rare and genetic diseases, neuroscience, immunology and infectious diseases across Latin America and the United States.
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 …
mAbxience and Sandoz have signed a global collaboration agreement to develop and commercialize a biosimilar candidate of emicizumab, targeting the haemophilia A market valued at $5.7 billion.
Brazil’s Health Ministry has formally asked Conitec to evaluate semaglutide and liraglutide for public-system coverage, opening a process that could reshape the country’s obesity-drug market.
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 …
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.
Eli Lilly agreed to acquire Merida Biosciences for up to $2.9 billion, adding a precision antibody-targeting platform to its immunology pipeline as the company’s 2026 acquisition total surpasses $31 billion.
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.
Anvisa cancelled Elevidys’s conditional registration on August 24 at Roche’s request, citing insufficient safety and efficacy data — ending Brazilian access to the country’s most expensive approved drug.
The FDA has approved Revolution Medicines’ daraxonrasib (Rasonque) for metastatic pancreatic adenocarcinoma, after a phase III trial of 500 patients showed median overall survival of 13.2 months versus 6.7 months …
Anvisa has approved datopotamab deruxtecan (Datroway) for adults with advanced EGFR-mutated non-small cell lung cancer in Brazil, expanding targeted therapy options in one of oncology’s most active segments.
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