No Trial Waiver: CDSCO Panel Directs Sun Pharma to Run Phase III Study for Somatropin Liquid Injection Citing Lack of India-Specific Data Susmita Roy21 Nov 2025 4:26 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has opined that the drug major Sun...
CDSCO Panel Asks Pure and Cure Healthcare To Revise Phase III Protocol of Tapinarof Cream 1% for Adult Psoriasis Susmita Roy17 Nov 2025 7:01 PM ISTNew Delhi: In response to the proposal submitted by Pure and Cure Healthcare, the Subject Expert Committee (SEC) on Dermatology and Allergy,...
CDSCO Panel Asks Shilpa Biologicals to Revise Phase III Protocol for Recombinant Human Serum Albumin Study Susmita Roy4 Nov 2025 4:39 PM ISTNew Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has sought major revisions in...
MSN Labs Secures SEC Nod for Phase III Trial of Vibegron 75 mg, Excluding Refractory OAB Patients Susmita Roy2 Nov 2025 12:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has approved MSN Laboratories to conduct a...
Alkem Labs Gets CDSCO Panel Nod for conducting Phase III study of Semaglutide tablet Susmita Roy14 Oct 2025 5:23 PM ISTNew Delhi: Alkem Laboratories has got the go-ahead from the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control...
Zydus Gets CDSCO Panel Nod for Phase III Trial of Dextromethorphan, Phenylephrine Cough Syrup FDC Susmita Roy6 Oct 2025 7:59 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has granted permission to Zydus Healthcare...
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 Akums for Detailed Data on Phase III Eye Drop Trial Parthika Patel23 Sept 2025 4:03 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has sought additional clarifications from...
CDSCO Panel Asks Wockhardt to Revise Phase III Study Protocol for Nafithromycin, Seeks Dosing, Control Arm Changes Susmita Roy16 Sept 2025 8:01 PM ISTNew Delhi: The Subject Expert Committee (SEC), which functions under the Central Drugs Standard Control Organisation (CDSCO), has recommended...
Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus' Phase III CT Waiver Request for Voclosporin Susmita Roy13 Sept 2025 6:13 PM ISTNew Delhi: Citing lack of sufficient efficacy and safety data to prove that the dose requirement in the Indian population is adequate, the Subject...
Pembrolizumab Significantly Improves Event-Free Survival in Head and Neck Cancer: NEJM Dr Riya Dave29 Aug 2025 10:15 PM ISTAccording to a recent study adding perioperative pembrolizumab to standard therapy such as surgery and radiotherapy with or without cisplatin...
Revise Phase III Trial Protocol for Roflumilast Cream: CDSCO Panel Tells Sun Pharma Susmita Roy20 Aug 2025 4:20 PM ISTNew Delhi: Following a thorough discussion on the proposed Phase III clinical trial protocol for roflumilast cream, the Subject Expert Committee (SEC)...
