Verified regulator approvals and drug-status explainers with evidence and India availability caveats.
CDSCO’s 26 October 2026 notice concerns misleading or false claims for FatX solution marketed under a cosmetic registration. What clinicians and consumers should verify before aesthetic procedures.
FDA has approved tucatinib with trastuzumab and pertuzumab for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy.
FDA’s Center for Devices and Radiological Health listed four new device classification actions on 5 October 2026, spanning cardiovascular monitoring, focused ultrasound, hereditary cancer testing and toxicology systems.
The FDA has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary valve designed to be expanded after implantation as a child grows.
FDA’s September 2026 notable approvals list includes Camzyos (mavacamten) as the first drug approved to improve functional capacity and symptoms in children with a rare inherited heart condition.
FDA approval of tiratricol (Emcitate) for peripheral thyrotoxicosis in MCT8 deficiency: what changed, evidence limits, safety and India implications.
What the FDA approval of ropeginterferon alfa-2b-njft for adults with essential thrombocythemia means—and what it does not establish in India.
An evidence-focused explainer of the FDA accelerated approval of sevabertinib, including limitations and India regulatory status.
FDA has approved zilganersen as the first treatment for Alexander disease. Review the mechanism, trial evidence, safety signals and important limitations.
