Tag: CDSCO
Optimus Pharma Secures Regulatory Approval for Non-Steroidal Tapinarof Cream to Treat Plaque Psoriasis
Optimus Pharma, a leading Indian pharmaceutical manufacturer and subsidiary of Sekhmet Pharmaventures, announced that it has received regulatory marketing approval for Tapinarof cream, an...
Enhertu Shows Better Results Than Standard Treatment in Lung Cancer Trial
AstraZeneca and Daiichi Sankyo announced that their antibody-drug conjugate Enhertu (trastuzumabderuxtecan) has achieved a statistically significant and clinically meaningful improvement in progression-free survival in the Phase...
Argenx’s Efgartigimod Clears Phase 3, Bringing New Hope for Autoimmune Myositis
argenx SE (Euronext & Nasdaq: ARGX) reported on August 17 that its Phase 3 ALKIVIA trial of subcutaneous efgartigimod (marketed as VYVGART Hytrulo) achieved its primary goal in...
Pfizer-Valneva Lyme Vaccine Clears Key EU Regulatory Step
Pfizer Inc. and Valneva SE announced that the European Medicines Agency has formally accepted for review the Marketing Authorization Application for their jointly developed Lyme disease...
Telangana Government Merges Food Safety and Drugs Control Departments to Form Unified Authority ‘TG SAFE’
In a major regulatory and administrative reform, the Government of Telangana has merged the Food Safety Department and the Drugs Control Department into a...
Caplin Point Laboratories Signs ₹925 Crore MoU to Establish Four New Manufacturing Units in Tamil Nadu
Caplin Point Laboratories Ltd has signed a Memorandum of Understanding (MoU) committing an investment of ₹925 crore to establish four new state-of-the-art pharmaceutical manufacturing...
