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Roche's Divarasib Outperforms First-Generation KRAS G12C Inhibitors in Phase 3 Lung Cancer Trial
Roche's investigational KRAS G12C inhibitor divarasib demonstrated superior progression-free and overall survival over approved first-generation therapies in the Phase III Krascendo 1 trial, marking a significant advance in the treatment of previously treated KRAS G12C-mutated non-small cell lung cancer.
Newron Provides Update Following Type A Meeting with the US FDA
Newron has provided an update following its Type A meeting with the US Food and Drug Administration (FDA), outlining the steps required to resume US enrollment in the phase 3 ENIGMA-TRS 2 schizophrenia study.
Shantha Biologics Announces Strategic Cartridge Fill-Finish Collaboration
Shantha Biologics has announced a cartridge fill-finish collaboration with Novo Nordisk, strengthening high-quality biologics manufacturing and global healthcare partnerships.
Novartis Secures European Commission Approval for Itvisma in SMA
The European Commission (EC) has approved Novartis' Itvisma, the first gene replacement therapy in the European Union (EU) for a broad population with spinal muscular atrophy (SMA), including children, adolescents, and adults.
Lupin Secures EMA Approval for Expanded NaMuscla Pediatric Use
Lupin has received EMA approval to expand the pediatric indication of NaMuscla, including two new capsule strengths of 62 mg and 83 mg.
Syngene International Appoints Siddharth Mittal as Managing Director and CEO
Siddharth Mittal’s appointment as Managing Director and CEO to accelerate Syngene International’s global growth, strengthen execution and enhance its CRDMO leadership.
Centre Revises Drugs Rules for Cell and Gene Therapies
The Centre has amended the Drugs Rules, 1945 to bring advanced cell and gene therapies under the Centrally License Approving Authority (CLAA), to include cell and stem cell-derived products, gene therapeutics and xenografts.
China Approves Hengrui Pharma's Water-Free Cyclosporine Eye Drop for Dry Eye Disease
China's drug regulator has approved Hengrui Pharma's Heng Yi, the country's first water-free 0.1 percent cyclosporine ophthalmic solution, expanding treatment options for patients with dry eye disease through Novaliq's EyeSol technology.
INTENT Biologics Secures FDA Breakthrough Therapy Tag for Diabetic Foot Ulcer Treatment Candidate
INTENT Biologics' PEP Biologic receives FDA Breakthrough Therapy designation for diabetic foot ulcers, accelerating development of its first-in-class exosome-based regenerative treatment aimed at improving healing outcomes in chronic wounds.
La Chandra Pharmalab Secures US FDA Clearance for Gujarat Hormone API Facility
La Chandra Pharmalab has received a US FDA Establishment Inspection Report (EIR) for its Banaskantha hormone API manufacturing facility, reinforcing its position in regulated markets and advancing India's capabilities in hormone API manufacturing.
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