Biolab, a Brazilian pharmaceutical company, has been selected by the UN-backed Medicines Patent Pool to manufacture and sell baloxavir marboxil (Xofluza), Roche’s single-dose oral influenza treatment, in Brazil under a …
Biolab, a Brazilian pharmaceutical company, has been selected by the UN-backed Medicines Patent Pool to manufacture and sell baloxavir marboxil (Xofluza), Roche’s single-dose oral influenza treatment, in Brazil under a …
The FDA has approved a label update for sotatercept (Winrevair) incorporating HYPERION trial data, extending the drug’s clinical evidence base to recently diagnosed pulmonary arterial hypertension patients on background therapy.
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 …
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.
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.
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 …
The first new-class painkiller in decades has near-universal US coverage and negligible sales — and no clear path to Latin American patients.
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