Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan Written By Dr. Divya Colin29 Jan 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Lupin for the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus...
Biological E gets CDSCO Panel Nod To study vaccine for 6- 8 weeks old infants Written By Dr. Divya Colin28 Jan 2024 6:00 PM ISTNew Delhi: Reviewing the Phase I clinical trial report, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Roche's proposal for marketing Atezolizumab Injection for Subcutaneous route rejected by CDSCO Panel Written By Dr. Divya Colin27 Jan 2024 6:00 PM ISTNew Delhi: Rejecting the drug major Roche's proposal to market the anti-cancer drug Atezolizumab Injection (1875mg/15ml vial) (Tecentriq) for a new...
Micro Lab Gets CDSCO panel Nod To Manufacture and Market Ebastine plus Phenylephrine FDC Written By Dr. Divya Colin26 Jan 2024 6:00 PM ISTNew Delhi: Micro Labs has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
Novo Nordisk Gets CDSCO Panel Nod to Study Ziltivekimab Written By Dr. Divya Colin25 Jan 2024 6:00 PM ISTNew Delhi: The drug major Novo Nordisk has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Drug Alert: 78 Drug Samples including Alkem's Pan 40 Flagged Written By Dr. Divya Colin24 Jan 2024 6:17 PM ISTNew Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drug Standard Control Organisation (CDSCO) has flagged 78 medicine...
Lupin Gets CDSCO Panel Nod to Study FDC of Fluticasone, Glycopyrronium, Vilanterol Inhalation Powder Written By Dr. Divya Colin23 Jan 2024 6:00 PM ISTNew Delhi: The drug major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Zydus Healthcare Gets CDSCO Nod to study Fluticasone Furoate plus Vilanterol Trifenatate FDC Written By Dr. Divya Colin22 Jan 2024 6:00 PM ISTNew Delhi: The drug major Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit Modified Informed Consent Form with details: CDSCO Panel Tells Sanofi om Multiple Sclerosis Drug Tolebrutinib Written By Dr. Divya Colin21 Jan 2024 6:00 PM ISTNew Delhi: Reviewing the Phase III clinical study protocol of Tolebrutinib presented by the drug major Sanofi, the Subject Expert Committee (SEC)...
Bharat Biotech Gets CDSCO Panel Nod To Manufacture Rotavirus Vaccine Live Attenuated, Oral Dr. Divya Colin20 Jan 2024 6:00 PM ISTNew Delhi: The vaccine major Bharat Biotech has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Serum Institute of India Gets CDSCO Panel Nod to Study Yellow Fever Vaccine Written By Dr. Divya Colin19 Jan 2024 6:00 PM ISTNew Delhi: The vaccine maker Serum Institute of India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug...
Pfizer Gets CDSCO Panel Nod to Study Sisunatovir in Adults With Respiratory Syncytial Virus Infection Written By Dr. Divya Colin18 Jan 2024 6:00 PM ISTNew Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
