CDSCO Panel grants Pfizer's protocol amendment proposal for Tofacitinib Dr. Divya Colin25 Dec 2022 4:42 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol...
Submit Revised CT Protocol of FDC Gabapentin,Lidocaine Gel: CDSCO panel tells Akums Drugs Dr. Divya Colin25 Dec 2022 4:23 PM ISTNew Delhi: Reviewing the justification and Phase III clinical trial protocol presented by the drug-maker Akums Drugs & Pharmaceuticals for the...
Synokem Pharama gets CDSCO panel nod to manufacture, market Naftifine HCL Cream 2% Dr. Divya Colin22 Dec 2022 6:00 PM ISTNew Delhi: The drug major Synokem Pharmaceutical has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug...
Conduct CT in Indian population: CDSCO Panel Tells AstraZeneca for Anifrolumab Dr. Divya Colin19 Dec 2022 6:00 PM ISTNew Delhi: Highlighting that the there is no study data available in Indian population for monoclonal antibody Anifrolumab 150mg/ml concentrate for...
CDSCO opines J&J to submit details of Anticancer Drug Teclistamab approval in EU, US Dr. Divya Colin15 Dec 2022 6:00 PM ISTNew Delhi: In response to the drug major Johnson & Johnson proposal to import and market Teclistamab sterile liquid in vial 30mg/vial and...
Submit in vitro data and comparative data: CDSCO Tells Dr Reddy's on Icosapent Ethyl Capsule Dr. Divya Colin13 Dec 2022 6:00 PM ISTNew Delhi: Noting that the effect of Icosapentether on the risk of pancreatitis in patients with severe hypertriglyceridemia has yet to be determined,...
Rationale to conduct trial of Tozorakimab is not adequate: CDSCO tells AstraZeneca Dr. Divya Colin11 Dec 2022 6:00 PM ISTNew Delhi: Citing that the rationale for conduct of the proposed trial of COPD (Chronic obstructive pulmonary disease) drug Tozorakimab is not...
Zydus Gets CDSCO Panel Nod To Study Follitropin alfa Dr. Divya Colin8 Dec 2022 6:00 PM ISTNew Delhi: The drug major Zydus has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Cipla Gets CDSCO Panel Nod To Manufacture, Market FDC Tamsulosin plus Solifenacin Dr. Divya Colin7 Dec 2022 6:00 PM ISTNew Delhi: Pharmaceutical major, Cipla has got a go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Revise phase III CT protocol of Recombinant Rabies G Protein Vaccine to add safety: CDSCO Panel tells Cadila Dr. Divya Colin4 Dec 2022 1:44 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the vaccine...
Sun Pharma gets CDSCO panel nod to manufacture, market Esomeprazole dual release gastroresistant tablets Susmita Roy4 Dec 2022 1:12 PM ISTNew Delhi: Pharmaceutical major Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
AstraZeneca gets CDSCO Panel nod to market anticancer drug Acalabrutinib Susmita Roy3 Dec 2022 6:00 PM ISTNew Delhi: In a significant development, granting the proposal presented by drug major AstraZeneca Pharma India, the Subject Expert Committee (SEC)...
