CDSCO Panel Directs Malik Lifesciences to Revise Phase III Trial Protocol for Tamsulosin, Dutasteride, Tadalafil FDC Parthika Patel3 Oct 2025 7:17 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Malik Lifesciences Pvt Ltd to...
MSN Lab gets CDSCO panel nod for Phase IV CT of Tofacitinib Tablets 10 mg Susmita Roy2 Oct 2025 12:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to MSN...
SEC Recommends Phase III Trial of MSN Labs' Vibegron Against Mirabegron in Overactive Bladder Parthika Patel2 Oct 2025 10:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended granting permission to MSN...
Not All Combipacks Are New Drugs: CDSCO Defines Approval Rules for Lyophilized Injections Susmita Roy1 Oct 2025 4:50 PM ISTNew Delhi: The Central Drugs Standard Control Organization (CDSCO) has issued a notice clarifying the regulatory pathway for approval of combipack...
Bombay HC Quashes Maharashtra FDA, CDSCO Stop-Production Orders Against 2 Pharma Firms Susmita Roy30 Sept 2025 4:08 PM ISTMumbai: The Bombay High Court has struck down orders issued by the Maharashtra Food and Drug Administration (FDA) and the Central Drugs Standard...
Intas Pharma Told to Narrow Margins, Extend Duration in Pembrolizumab Trial Protocol Farhat Nasim30 Sept 2025 3:09 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has directed Intas Pharmaceuticals Ltd. to...
MSN Lab gets CDSCO panel nod for Phase IV CT of Tofacitinib Oral Solution Susmita Roy29 Sept 2025 9:56 PM ISTNew Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to MSN...
Health Ministry Bans 34 Key Antibiotics, Antivirals for Animal Use, See List Susmita Roy29 Sept 2025 9:51 PM ISTNew Delhi: Through a recent Gazette notification, the Ministry of Health and Family Welfare has notified a ban on the import, manufacture, sale, and...
CDSCO Panel Recommends Updating Prescribing Information for Sanofi's Vaccine Susmita Roy28 Sept 2025 1:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended updation of the...
CDSCO Panel Approves Novo Medi Sciences' Phase III Booster Study of PCV13 Pneumococcal Vaccine in Infants Susmita Roy27 Sept 2025 6:13 PM ISTNew Delhi: Reviewing the revised Phase III clinical trial protocol for booster dose administration of the 13-valent Pneumococcal Polysaccharide...
CDSCO Panel Asks Takeda to Submit Full Phase III Data on Dengue Tetravalent Vaccine Susmita Roy26 Sept 2025 4:21 PM ISTNew Delhi: Reviewing India specific blinded interim safety analysis report of the ongoing Phase III clinical trial of Dengue tetravalent vaccine...
Bharat Biotech Gets SEC Nod to Begin Phase III Trial of Inactivated Chikungunya Vaccine Susmita Roy26 Sept 2025 4:18 PM ISTNew Delhi: Noting the results of the Phase II trial for the Inactivated Chikungunya vaccine, the Subject Expert Committee (SEC) functioning under the...
