Lupin Secures U.S. FDA Tentative Approval for Enzalutamide Tablets
Lupin Limited (Lupin) the Mumbai, India based global pharma major earlier this week had announced that the company has received tentative approval from the...
Mayo Clinic Finds Common Surgical Drug Could Reduce Risk of Liver Failure
Researchers at Mayo Clinic and Michigan State University have uncovered a potentially life-saving application for tranexamic acid, a widely used clot-preserving medication, in the context of...
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...