Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Vedolizumab for Ulcerative Colitis Dr. Divya Colin13 Aug 2024 6:00 PM ISTNew Delhi: Intas Pharmaceuticals has got the go-ahead from the Subject Expert Committee ( SEC) functional under the Central Drug Standard Control...
Insufficient CT data in female population: CDSCO Panel tells Alkem Laboratories on Relugolix Tablets Dr. Divya Colin31 July 2024 6:00 PM ISTNew Delhi: Noting insufficient clinical trial data in the female population for applied indication, the Subject Expert Committee (SEC) functional...
Tisotumab Vedotin Shows Superior Efficacy in Recurrent Cervical Cancer Treatment, reveals research Dr Riya Dave26 July 2024 8:45 PM ISTResearchers in a recent study have found that tisotumab vedotin, a novel therapy, significantly enhances survival outcomes in patients with recurrent...
Akums Drugs and Pharmaceuticals Gets CDSCO Panel Nod To study Dapagliflozin plus Bisoprolol FDC Dr. Divya Colin12 Jun 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to the...
Pamrevlumab Shows No Significant Benefit in Slowing Lung Function Decline in Idiopathic Pulmonary Fibrosis: JAMA Dr Riya Dave27 May 2024 8:00 AM ISTResearchers have found that pamrevlumab, a monoclonal antibody, does not significantly slow the decline in lung function for patients with idiopathic...
Submit preliminary analysis of primary data of subjects above 18 years in India: CDSCO Panel Tells Sanofi on Amlitelimab study Dr. Divya Colin19 May 2024 6:00 PM ISTNew Delhi: After considering the phase III clinical study protocol of the monoclonal antibody Amlitelimab in the treatment of moderate-to-severe...
Submit Source Data of Phase III CT Report: CDSCO Panel Tells Eris Lifesciences on Metoprolol Succinate plus Dapagliflozin FDC Dr. Divya Colin11 May 2024 6:00 PM ISTNew Delhi: Reviewing the Phase III clinical trial report of fixed-dose combination (FDC) drug, Metoprolol Succinate sustained released 25mg/50mg plus...
Eli Lilly Gets CDSCO Panel Nod to Study Lepodisiran Dr. Divya Colin25 April 2024 6:00 PM ISTNew Delhi: The drug major Eli Lilly has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Conduct Phase-III clinical trial: CDSCO Panel tells Abbott on Ademetionine for Injection 400mg Dr. Divya Colin10 April 2024 6:00 PM ISTNew Delhi: Responding to the proposal of import and marketing of Ademetionine for injection 400mg, the Subject Expert Committee (SEC) functional under...
Conduct Randomized Control Phase III CT in Indian Population: CDSCO Panel Tells Pfizer on Rimegepant Dr. Divya Colin15 March 2024 6:00 PM ISTNew Delhi: Rejecting the proposal for local Phase III clinical trial waivers, the Subject Expert Committee (SEC) functional under the Central Drug...
Novel Single-Dose Dengue Vaccine Shows High Efficacy in Phase 3 Trial Dr Riya Dave2 Feb 2024 11:15 AM ISTIn a breakthrough development, the Butantan-Dengue Vaccine (Butantan-DV), an investigational single-dose, live, attenuated, tetravalent vaccine...
Submit Modified Informed Consent Form with details: CDSCO Panel Tells Sanofi om Multiple Sclerosis Drug Tolebrutinib 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)...
