Submit Justification and Rational: CDSCO Panel tells Pfizer on protocol amendment proposal for Palbociclib Dr. Divya Colin20 Dec 2023 6:25 PM ISTNew Delhi: In response to the proposal presented by the drug major Pfizer for the protocol amendment, the Subject Expert Committee (SEC) functional...
Lupin gets CDSCO Panel nod for Rifapentine Dispersible Tablet 150 mg Dr. Divya Colin19 Dec 2023 7:36 PM ISTNew Delhi: Granting the local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Conduct BE study and clinical trial: CDSCO Panel tells Cipla on Formoterol Fumarate Dihydrate, glycopyrronium inhaler Dr. Divya Colin19 Dec 2023 6:58 PM ISTNew Delhi: Rejecting the proposal for clinical trial and bioequivalence (BE) study waiver presented by drug major Cipla, the Subject Expert Committee...
AstraZeneca gets CDSCO panel nod to study anti-cancer drug Capivasertib Dr. Divya Colin17 Dec 2023 6:00 PM ISTNew Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDCÂ Dr. Divya Colin17 Dec 2023 5:30 PM ISTNew Delhi: Approving to conduct the bioequivalence (BE) study of the antidiabetic drug combination Repaglinide plus Voglibose plus Metformin...
Sun Pharma gets CDSCO panel nod to manufacture, and market Etifoxine HCL capsules for anxiety Susmita Roy16 Dec 2023 6:00 PM ISTNew Delhi: The drug major Sun Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
COPD treatment: CDSCO nod to AstraZeneca India to market triple drug combination inhalation aerosol Ruchika Sharma15 Dec 2023 4:30 PM ISTBangalore: Biopharmaceutical company AstraZeneca India has announced that it has received Central Drugs Standard Control Organisation (CDSCO)...
AstraZeneca gets CDSCO panel Nod to study anti-cancer drug Volrustomig in women with cervical cancer Dr. Divya Colin14 Dec 2023 6:00 PM ISTNew Delhi: The drug major AstraZeneca has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel revises warning statement of Sanofi's antidiabetic FDC Insulin Glargine plus Lixisenatide Dr. Divya Colin13 Dec 2023 6:00 PM ISTNew Delhi: Approving the amendment in the warning statement for Sanofi's Fixed Ratio Combination of Insulin Glargine 100U/mL plus Lixisenatide 50...
Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Inavolisib Dr. Divya Colin12 Dec 2023 6:00 PM ISTNew Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
AstraZeneca gets a CDSCO panel Nod To study Rilvegostomig Dr. Divya Colin11 Dec 2023 6:00 PM ISTNew Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Conduct Phase III CT: CDSCO Panel Tells Akum Pharmaceutical on Antidiabetic FDC Dr. Divya Colin10 Dec 2023 6:00 PM ISTNew Delhi: Rejecting the proposal for the clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
