First patient randomized in Ropanicant Phase 2b trial for Major Depressive Disorder: Suven Life Sciences Written By Ruchika Sharma16 July 2025 2:47 PM ISTHyderabad: Suven Life Sciences has announced that the first patient has been randomized in its Phase-2b clinical trial evaluating Ropanicant, a...
Sanofi intravitreal gene therapy wins USFDA fast track designation for geographic atrophy due to age-related macular degeneration Written By Ruchika Sharma16 July 2025 1:30 PM ISTParis: Sanofi has received fast track designation from the US Food and Drug Administration (FDA) for SAR446597, a one-time intravitreal gene therapy...
Shilpa Medicare Dabaspet unit gets VAI classification from USFDA Written By Ruchika Sharma16 July 2025 12:14 PM ISTKarnataka: Shilpa Medicare Limited has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI)...
Biocon Biologics expands biosimilar insulin portfolio with USFDA nod of Kirsty Written By Ruchika Sharma16 July 2025 11:30 AM ISTKarnataka: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has received approval...
Boehringer Ingelheim, LEO Pharma collaborate to commercialize, further develop Spevigo Written By Ruchika Sharma16 July 2025 10:30 AM ISTBoehringer Ingelheim set to receive EUR 90 million as upfront payment, along with milestone payments and tiered royalties.
Zydus Gets SEC Nod to Begin Phase IV Trial of Dydrogesterone ER for Habitual Miscarriage Parthika Patel15 July 2025 8:21 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Reproductive division of the Central Drugs Standard Control Organisation (CDSCO) has granted...
CDSCO Panel Approves GSK's Proposal to Double Indian Patient Pool in Dostarlimab Trial Parthika Patel15 July 2025 7:34 PM ISTNew Delhi: In a recent regulatory development, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control...
Aurobindo Pharma to manufacture, supply HIV treatment cabotegravir across 133 countries Written By Ruchika Sharma15 July 2025 5:46 PM ISTNew Delhi: Hyderabad-based drugmaker Aurobindo Pharma will produce and supply Cabotegravir, a long-acting injectable HIV treatment, across 133...
Zydus Lifesciences bags USFDA okay for Celecoxib Capsules for juvenile rheumatoid arthritis treatment in children Written By Ruchika Sharma15 July 2025 5:19 PM ISTCelecoxib capsules will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.
Merck to begin Phase 3 trials for investigational once monthly HIV prevention pill Written By Ruchika Sharma15 July 2025 3:30 PM ISTRahway: Merck, known as MSD outside of the United States and Canada, has announced the initiation of the EXPrESSIVE Phase 3 clinical trials,...
GSK application for expanded RSV vaccine Arexvy use for adults 18-49 accepted for review by USFDA Written By Ruchika Sharma15 July 2025 2:30 PM ISTLondon: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of...
Johnson & Johnson Medtech bags USFDA approval for updated Varipulse Platform Irrigation Rate Written By Ruchika Sharma15 July 2025 1:30 PM ISTNew Brunswick: Johnson & Johnson MedTech has announced the U.S. Food and Drug Administration (FDA) approval of an update to the VARIPULSE...
