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Lundbeck Receives U.S. FDA Orphan Drug Designation for Investigational Therapy in Endogenous Cushing’s Syndrome

H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational program for the treatment of endogenous Cushing’s syndrome, a...

U.S. FDA Grants Accelerated Approval for Bayer’s Sevabertinib as First-Line Therapy in Advanced HER2-Mutant NSCLC Following 75% Response Rate

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib, an oral,...

MSD Inaugurates New Technology Centre in Hyderabad to Drive Global Healthcare Innovation and Digital Capabilities

MSD (Merck & Co., Inc.), one of the world's leading global life sciences companies, has officially inaugurated its...

Bharat Technology Announces BT-PHARMACON 2K26 with Focus on Indigenous Pharma Innovation

Bharat Technology is set to organise BT-PHARMACON 2K26, an ANRF-sponsored national conference on September 26–27, 2026, at the Eastern Zonal...

ChrysCapital to Acquire 20-25% Stake in Linux Laboratories for ₹600 Crore

Private equity firm ChrysCapital is all set to acquire a strategic stake in Linux Laboratories, a Chennai-based specialty pharmaceutical company focused on central nervous...

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...

Union Home Minister Amit Shah Launches ‘PM Family Care Tracker’ Pilot Project in Gandhinagar

Union Home Minister and Minister of Cooperation Shri Amit Shah inaugurated the pilot project for the "PM Family Care Tracker," a groundbreaking integrated monitoring system designed...

India’s Digital Health Landscape Set for Major Transformation on June 29

Union Health Minister Shri Jagat Prakash Naddawill formally unveil a landmark suite of digital health tools at Vigyan Bhawan, New Delhi, on Monday, June 29, 2026. The event marks...