Tag: CDSCO
Viatris’ VR-205 Shows Strong Phase 3 Results in Japanese IgA Nephropathy Patients
Viatris Inc. (Nasdaq: VTRS) - reported encouraging top-line data from a Phase 3 trial of VR-205, a targeted-release budesonide therapy marketed elsewhere as Tarpeyo and Kinpeygo, in Japanese adults living...
Shilpa Biologicals Activates GMP-Certified ADC Manufacturing Hub in Dharwad, India
Shilpa Biologicals, the biologics arm of Raichur-based Shilpa Medicare Ltd., has formally activated its antibody–drug conjugate (ADC) drug substance manufacturing facility in Dharwad, India. The plant is currently...
New Hope for Thyroid Eye Disease Treatment as FDA Approves Lumvoa
Waltham-based Viridian Therapeutics (Nasdaq: VRDN) has secured U.S. Food and Drug Administration clearance for Lumvoa™ (veligrotug-vvze), marking the company's debut as a commercial-stage biotech and...
Government Proposes Faster Regulatory Approvals for Medical Device Manufacturers
India's Ministry of Health and Family Welfare has published draft amendments to the Medical Devices Rules, 2017, via G.S.R. 515(E) in the Extraordinary Gazette...
No free passes: FDA tightens rule against Foreign Tobacco Manufactures
The U.S. Food and Drug Administration (FDA) issued a proposed rule aimed at strengthening oversight of foreign tobacco product manufacturers and blocking illegal products...
CDSCO orders SUGAM Portal for Vaccine Post-Approval Applications from July 1
The Central Drugs Standard Control Organization (CDSCO) has announced that all applications for Post-Approval Changes in Registration Certificates and Import Licences for Human Vaccines...
