Submit post-marketing safety data of Belumosudil in Chronic graft versus host disease: CDSCO Panel Tells Sanofi Dr. Divya Colin21 April 2024 6:00 PM ISTNew Delhi: Responding to the proposal presented by the drug major Sanofi to import and market Belumosudil tablets 200 mg, the Subject Expert Committee...
Dr Reddy's Laboratories gets CDSCO Panel Nod To Import and Market Toripalimab 240mg solution for infusion Dr. Divya Colin20 April 2024 6:00 PM ISTNew Delhi: Noting an unmet medical need for recurrent locally advanced/metastatic nasopharyngeal carcinoma (RM-NPC) in India, the Subject Expert...
Dr.Reddy's Labs gets CDSCO Panel Nod To Manufacture, Market anti-cancer drug Lenalidomide 20mg additional strength Dr. Divya Colin19 April 2024 6:00 PM ISTNew Delhi: The drug major Dr Reddy's Labs has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Reduce PSA level to less than 4 in inclusion criteria: CDSCO Panel Tells Akum Drugs and Pharmaceuticals on FDC Dutasteride plus Silodosin Dr. Divya Colin18 April 2024 6:00 PM ISTNew Delhi: Reviewing the active post-marketing surveillance (PMS) protocol of fixed-dose combination (FDC) Dutasteride plus Silodosin presented by...
Bharath Biotech Gets CDSCO Panel Nod To Manufacture Cholera Vaccine, Inactivated, Oral for 1 year age and above Dr. Divya Colin17 April 2024 6:00 PM ISTNew Delhi: Noting the outcome of inspections of clinical trial sites conducted by the Central Drug Standard Control Organisation (CDSCO), the Subject...
Glenmark Pharmaceuticals Gets CDSCO Panel Nod to Study Lobeglitazone Sulfate, Glimepiride FDC Table Dr. Divya Colin16 April 2024 6:00 PM ISTNew Delhi: Glenmark Pharmaceuticals, a major pharmaceutical company, has received approval from the Subject Expert Committee (SEC) operating under the...
Torrent Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Dr. Divya Colin15 April 2024 6:00 PM ISTNew Delhi: Reviewing the justification presented by the drug major Torrent Pharmaceutical, the Subject Expert Committee (SEC) functional under the...
Drug Safety Alert: IPC Flags ADR Linked To Cefuroxime, Nimesulide, Dutasteride plus Tamsulosin and some Beta-blockers Susmita Roy14 April 2024 6:00 PM ISTNew Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert, has revealed adverse drug reactions linked with...
Submit analysis of clinical data of Asian, Indian Population: CDSCO Panel Tells AstraZeneca on Durvalumab Dr. Divya Colin13 April 2024 6:00 PM ISTNew Delhi: In response to the drug major AstraZeneca's proposal for the approval of additional indication of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL...
Submit global regulatory status of Atezolizumab for IV, SC route: CDSCO Panel Tells Roche Products India Dr. Divya Colin12 April 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Roche Products India for granting permission to import and market Atezolizumab...
CDSCO Panel grants AstraZeneca's proposal for withdrawing specific Indications of Olaparib Tablets Dr. Divya Colin11 April 2024 6:00 PM ISTNew Delhi: Reviewing the Clinical evidence presented by drug major AstraZeneca, the Subject Expert Committee (SEC) functional under the Central Drug...
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...
