CDSCO panel tells Abbott to present more data on Metronidazole Extended Release Tablet Dr. Divya Colin29 May 2022 2:13 PM ISTNew Delhi: Denying the pharmaceutical major Abbott Healthcare proposal to manufacture and market antibiotic Metronidazole Extended Release Tablet for...
There is no unmet need: CDSCO Panel rejects J&J proposal to Import and manufacture Paliperidone Palmitate Dr. Divya Colin29 May 2022 11:29 AM ISTNew Delhi: Citing that there is no unmet need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Amrita Vishwa Vidyapeetham gets CDSCO nod for Nanotex bone graft trial Ruchika Sharma27 May 2022 1:23 PM ISTThe synthetic bone graft, named Nanotex Bone, provides a first-of-its-kind solution in the world for patients who lose part of their lower jaw...
Biocon Biologics gets CDSCO panel nod to import, manufacture Insulin Aspart Injection Dr. Divya Colin25 May 2022 4:23 PM ISTNew Delhi: Approving the waiver of Phase III clinical trial in the country, the Subject Expert Committee (SEC) functional under Central Drug Standard...
Serum Institute seeks CDSCO permission for Phase-3 trial of Covovax as booster dose in children aged 2-18 Ruchika Sharma24 May 2022 12:03 PM ISTThe study will evaluate the immunogenicity and safety of the vaccine as a booster dose in comparison with the placebo.
AstraZeneca gets CDSCO nod to conduct Phase III CT of antineoplastic FDCs drug Dr. Divya Colin24 May 2022 10:45 AM ISTNew Delhi: Suggesting to increase the number of subjects in clinical trial to 34, from the proposed 24 subjects in India, the Subject Expert Committee...
Eli Lilly Kinsale gets CDSCO panel nod to import, market anticancer drug Selpercatinib Dr. Divya Colin20 May 2022 5:52 PM ISTNew Delhi: Granting the clinical trial waiver, the Subject Expert Committee ( SEC) of the Central Drugs Standard Control Organization (CDSCO) has...
Boehringer Ingelheim's empagliflozin gets CDSCO nod for heart failure with preserved ejection fraction Medical Dialogues Bureau19 May 2022 4:19 PM ISTNew Delhi: Boehringer Ingelheim, one of the world's leading, research-driven pharmaceutical companies, has received approval from the Central Drugs...
Justify dose of Bilastine: CDSCO Panel tells Glenmark on FDC of Bilastine, Dextromethorphan ,Phenylephrine Syrup Dr. Divya Colin17 May 2022 7:10 PM ISTNew Delhi: Rejecting the pharmaceuticals major Glenmark proposal for bioequivalence (BE) study waiver of fixed dose combination drug Bilastine 3.3mg...
Include more sites from govt hospitals: CDSCO panel tells Intas on Tofacitinib Ointment 2% CT study Dr. Divya Colin15 May 2022 12:30 PM ISTNew Delhi: Directing the pharma major Intas Pharma to include more study sites from government hospitals geographically distributed in the country,...
CDL Kasauli clears over 21 lakh Gennova Biopharma mRNA COVID vaccine doses: Sources Ruchika Sharma15 May 2022 10:30 AM ISTGennova's mRNA vaccine is an Omicron-specific vaccine and has already tweaked its mRNA platform that will target Omicron.
Drug alert: CDSCO flags 27 medicine batches as not of standard quality Ruchika Sharma14 May 2022 2:48 PM ISTNew Delhi: In its latest drug safety alert, the Central Drugs Standard Control Organization (CDSCO) has flagged 27 medicine batches as not of Standard...
