Submit revised BE study protocol: CDSCO panel tells Laurus Labs on Carglumic Acid Dispersible Tablets Dr. Divya Colin25 March 2023 5:45 PM ISTNew Delhi: Rejecting drug maker Laurus Lab's proposal for clinical trial waiver of Carglumic acid dispersible tablets 200mg, the subject committee...
Novartis gets CDSCO panel nod for Phase III CT of anticancer drug Ianalumab Dr. Divya Colin23 March 2023 6:00 PM ISTNew Delhi: In a significant development, pharmaceutical major Novartis has got the go-ahead from the Subject Expert Committee (SEC) functional under...
CDSCO panel grants GSK's proposal for Updation of Package Insert of Infanrix Hexa Vaccine Dr. Divya Colin22 March 2023 6:00 PM ISTNew Delhi: Pharmaceutical major GSK has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Roche gets CDSCO panel nod to import, market anticancer Drug Polatuzumab vedotin Dr. Divya Colin21 March 2023 6:00 PM ISTNew Delhi: In a significant development, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO)...
CDSCO issued show cause notice to 31 firms following concerns over e-pharmacies: MoS Health Bharati Pravin Pawar Farhat Nasim20 March 2023 5:33 PM ISTCases concerning the quality of drugs, when reported, was taken up with the State Licensing Authority (SLA) concerned for necessary action under the...
CDSCO Panel approves Phase IV CT of Hetero-Trastuzumab marketed formulation Dr. Divya Colin19 March 2023 6:00 PM ISTNew Delhi: Drug major Hetero Biopharma has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
CDSCO Panel grants Sanofi's Protocol Amendment Proposal for Quadrivalent Meningococcal Conjugate Vaccine Dr. Divya Colin19 March 2023 5:45 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Sanofi Healthcare's...
Conduct PMS study for Hepatitis B Vaccine r-DNA : CDSCO Tells Biological E Dr. Divya Colin18 March 2023 6:00 PM ISTNew Delhi: Rejecting the pharmaceutical major Biological E proposal for waiving the post marketing surveillance (PMS) study, the Subject Expert...
Conduct Phase III CT : CDSCO panel tells AstraZeneca for anticancer drug Olaparib Film coated Tablet Dr. Divya Colin17 March 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the drug major...
AstraZeneca Gets CDSCO Panel nod to import, market Trastuzumab deruxtecan for breast cancer Dr. Divya Colin16 March 2023 6:00 PM ISTNew Delhi: Granting the local Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Continue CT with 30 ongoing Indian subjects: CDSCO panel tells Novo-Nordisk on Insulin Icodec Dr. Divya Colin15 March 2023 6:00 PM ISTNew Delhi: Based on the safety data of 30 Indian subjects in the global clinical trial of Insulin Icodec, the Subject Expert Committee (SEC)...
GSK gets CDSCO Panel nod to import, market anticancer drug Dostarlimab Susmita Roy14 March 2023 6:00 PM ISTNew Delhi: Highlighting the unmet medical need in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
