Tag: Drug approval
CDSCO Clarifies Approval Rules for Granules & Pellets, Bringing Regulatory Clarity to Pharma Industry
The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a comprehensive circular clarifying the regulatory and licensing...
FDA Grants Accelerated Approval to Sanofi’s Tzield® for Pediatric Stage 3 Type 1 Diabetes
The U.S. Food and Drug Administration has granted accelerated approval to Sanofi's Tzield® (teplizumab-mzwv) for children aged 8 to 17 years recently diagnosed with stage...
A Global Pediatric Milestone: WHO Pre qualifies First Malaria Treatment for Newborns and Young Infants
In a landmark step for global child health, the World Health Organization (WHO) has prequalified the world’s first malaria treatment specifically designed for newborns...
Johnson & Johnson to Acquire Atraverse Medical to Expand Cardiac Care Portfolio
Johnson & Johnson has entered into a definitive agreement to acquire Atraverse Medical, a medical device innovator focused on left-heart access technologies. The move...
India Expands COVID-19 Vaccine Portfolio with New Approvals Including Omicron JN.1 Variant Shot
India’s COVID-19 vaccination landscape continues to evolve, with the Central Drugs Standard Control Organization (CDSCO) releasing an updated list of approved vaccines as of...
Novo Nordisk’s Etavopivat Cracks Phase 3 Goals: A Potential New Standard of Care for Sickle Cell Disease
Novo Nordisk’s Etavopivat hits the mark in Pivotal Sickle Cell Study. Etavopivat, an oral, once-daily pyruvate kinase-R (PKR) activator displayed supercilious results showing 27%...