Submit safety, efficacy data of Indian Patients: CDSCO Panel Tells AstraZeneca on additional indication of Enhertu 100mg Dr. Divya Colin29 Dec 2023 6:15 PM ISTNew Delhi: In response to the drug major AstraZeneca's proposal for the additional indication of Trastuzumab Deruxtecan Powder Concentrate Solution...
AstraZeneca Gets CDSCO Panel Nod for Enhertu 100mg for additional indication of breast cancer Dr. Divya Colin25 Dec 2023 6:00 PM ISTNew Delhi: Noting an unmet medical need in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
J&J Gets CDSCO Panel Nod to study anti-cancer drug Talquetamab Dr. Divya Colin22 Dec 2023 6:00 PM ISTNew Delhi: The drug major Johnson and Johnson has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
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...
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...
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...
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...
Submit Clarification for Weight-based calculated fixed dose: CDSCO panel Tells J&J Over Teclistamab Dr. Divya Colin21 Aug 2023 6:00 PM ISTNew Delhi: Based on the proposal presented by drug major Johnson & Johnson for the protocol amendment of the anticancer drug Teclistamab, the...
CDSCO Panel denies Nacto Pharma's request To Waive Phase III CT of Anticancer Erdafitinib tablet Dr. Divya Colin13 Aug 2023 6:00 PM ISTNew Delhi: Rejecting the waiver of Phase III clinical trial proposal for Erdafitinib Tablets 3mg, 4mg, and 5mg, the Subject Expert Committee (SEC)...
CDSCO Panel Approves Roche's Protocol Amendment Proposal to Study Polatuzumab Vedotin Dr. Divya Colin2 July 2023 5:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment...
Bayer Pharma Gets CDSCO Panel Nod To Update Prescribing Information of Anti-cancer Drug Darolutamide Dr. Divya Colin1 July 2023 5:30 PM ISTNew Delhi: Bayer Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Submit safety and efficacy data: CDSCO panel Tells Zydus on Anticancer Drug Relugolix Dr. Divya Colin18 Jun 2023 10:00 AM ISTNew Delhi: In response to the drug major Zydus's proposal for the manufacture and marketing of the drug Relugolix 120 mg tablets, the Subject Expert...
