Cancer drug approvals, oncology market access, precision medicine and immuno-oncology across Latin America and the US.
Cancer drug approvals, oncology market access, precision medicine and immuno-oncology across Latin America and the US.
Telix Pharmaceuticals agrees to acquire ITM Isotope Technologies Munich for up to $2.35 billion, securing isotope supply and adding ITM-11, a Phase 3 neuroendocrine tumour candidate that received an FDA …
The FDA approved belzutifan plus lenvatinib for adults with advanced clear cell renal cell carcinoma after prior immunotherapy, adding a second approved indication for belzutifan in 2026 and expanding Merck …
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.
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.
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.
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.
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.
Vepdegestrant’s May 1 approval for ESR1-mutant advanced breast cancer marks the first PROTAC-class drug cleared by the FDA, with VERITAC-2 trial data showing a hazard ratio of 0.70 over fulvestrant.
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.
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