SC relief to GSK, junks plea claiming deficiency of service by Pharma company on account of alleged vaccine side effects Ruchika Sharma11 Sept 2023 3:14 PM ISTThe apex court said that non-mentioning of myositis as an adverse reaction in the literature accompanying the injection or on the vial, did not amount...
Generate Phase II Clinical Data on 20 Indian subjects for dose selection: CDSCO panel Tells Pfizer on Ritlecitinib Dr. Divya Colin10 Sept 2023 6:00 PM ISTNew Delhi: Noting that in the presented Phase II clinical trial data, no Indian subjects were involved and the study disease is very heterogeneous,...
MSN Lab gets CDSCO Panel Nod To Manufacture, Market Combi kit for Macitentan 10mg plus Tadalafil 20mg Dr. Divya Colin9 Sept 2023 6:00 PM ISTNew Delhi: Granting approval for Phase III clinical trial and bioequivalence (BE) study wavier, the Subject Expert Committee (SEC) functional under...
CDSCO raises alert on fake Lymphoma drug Adcetris Injection manufactured by Takeda Pharma Dr. Divya Colin8 Sept 2023 6:00 PM ISTNew Delhi: Concerning falsified versions of Adcetris Injection (Brentuximab Vedotin) manufactured by Takeda Pharmaceutical, the Central Drugs Standard...
Biocon Chief Kiran Mazumdar-Shaw appointed as member of Court of Regents at Royal College of Surgeons of Edinburgh Ruchika Sharma7 Sept 2023 6:15 PM ISTBengaluru: Kiran Mazumdar-Shaw, Executive Chairperson of Biocon Ltd. and Biocon Biologics Ltd., has been appointed as Regent of the Royal...
DCGI flags popular antacid Digene Gel, Abbott initiates recall Farhat Nasim6 Sept 2023 7:25 PM ISTNew Delhi: The popular antacid Digene gel has received a warning alert from the Drugs Control General of India (DCGI) following which batches of the...
Lupin Gets CDSCO Panel Nod To Manufacture, Market FDC of Glycopyrronium, Vilanterol Inhalation Powder Dr. Divya Colin5 Sept 2023 6:00 PM ISTNew Delhi: The drug major Lupin has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit Supportive Documents for safety of Fluticasone dose: CDSCO panel Tells Glenmark on FDC pulmonary drug Dr. Divya Colin4 Sept 2023 6:00 PM ISTNew Delhi: Based on the Phase III clinical trial protocol and justification for the inhalation toxicity of the fixed-dose combination (FDC) pulmonary...
Synokem Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug Sitagliptin plus Empagliflozin Dr. Divya Colin3 Sept 2023 6:00 PM ISTNew Delhi: The drug major Synokem Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Conduct Phase-III clinical trial in India: CDSCO panel tells Johnson and Johnson Over Guselkumab Dr. Divya Colin2 Sept 2023 6:00 PM ISTNew Delhi: Citing that there is no clinical data available on the Indian Population, the Subject Expert Committee (SEC) functional under the Central...
Sun Pharma Gets CDSCO panel Nod To Manufacture, Market Sitagliptin, Metformin, Glimepiride antidiabetic FDC Dr. Divya Colin1 Sept 2023 6:00 PM ISTNew Delhi: Based on the Phase III clinical trial report and bioequivalence (BE) study report of the antidiabetic fixed-dose combination (FDC) drug...
Synokem Gets CDSCO Panel Nod To Manufacture, Market antidiabetic FDC Pioglitazone, Vildagliptin Dr. Divya Colin31 Aug 2023 6:00 PM ISTNew Delhi: With the condition of conducting phase IV clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
