Drug Approval | February 27, 2025
Briefs: Emcure and Relonchem
USFDA inspection at Emcure Pharmaceuticals API facility
USFDA inspection at Emcure Pharmaceuticals API facility
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years
QUANTI clinical development program evaluated the efficacy and safety of the investigational MRI contrast agent gadoquatrane for a broad range of potential indications and in pediatric and adult patients
Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries
Final decision from the European Commission is anticipated within the coming months
Venus Remedies secures marketing authorization in Philippines
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun
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