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Tag: cdsco

You Searched For "cdsco"
CDSCO Panel grants Pfizers protocol amendment proposal for Tofacitinib

CDSCO Panel grants Pfizer's protocol amendment proposal for Tofacitinib

Dr. Divya Colin25 Dec 2022 4:42 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol...
Akums Drugs & Pharma opens new facility

Submit Revised CT Protocol of FDC Gabapentin,Lidocaine Gel: CDSCO panel tells Akums Drugs

Dr. Divya Colin25 Dec 2022 4:23 PM IST
New Delhi: Reviewing the justification and Phase III clinical trial protocol presented by the drug-maker Akums Drugs & Pharmaceuticals for the...
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma

Sun Pharma gets CDSCO Panel nod to study Tildrakuzimab

Dr. Divya Colin23 Dec 2022 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to study the...
Centre nod to Bharat Biotech nasal COVID vaccine iNCOVACC, to be availabile in private hospitals

Centre nod to Bharat Biotech nasal COVID vaccine iNCOVACC, to be availabile in private hospitals

Ruchika Sharma23 Dec 2022 3:31 PM IST
iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein.
Dr Mansukh Mandaviya inaugurates new building of CDSCO Bhawan, South Zone in Chennai

Dr Mansukh Mandaviya inaugurates new building of CDSCO Bhawan, South Zone in Chennai

Ruchika Sharma23 Dec 2022 1:30 PM IST
New Delhi: Union Minister of Health & Family Welfare Dr. Mansukh Mandaviya has virtually inaugurated the new building of CDSCO Bhawan, South...
Synokem Pharama gets CDSCO panel nod to manufacture, market Naftifine HCL Cream 2%

Synokem Pharama gets CDSCO panel nod to manufacture, market Naftifine HCL Cream 2%

Dr. Divya Colin22 Dec 2022 6:00 PM IST
New Delhi: The drug major Synokem Pharmaceutical has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug...
AstraZeneca Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

Conduct CT in Indian population: CDSCO Panel Tells AstraZeneca for Anifrolumab

Dr. Divya Colin19 Dec 2022 6:00 PM IST
New Delhi: Highlighting that the there is no study data available in Indian population for monoclonal antibody Anifrolumab 150mg/ml concentrate for...
Novo Nordisk gets CDSCO Panel nod to study NN0365-3769

Novo Nordisk gets CDSCO Panel nod to study NN0365-3769

Dr. Divya Colin18 Dec 2022 5:00 PM IST
New Delhi: In a significant development, the drug major Novo-Nordisk has got approval from the Subject Expert Committee (SEC) functional under the...
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy

Novartis gets CDSCO panel nod to study anticancer drug JDQ443

Dr. Divya Colin17 Dec 2022 6:00 PM IST
New Delhi: Pharmaceutical major Novartis, has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
DCGI calls out WHO for prematurely blaming Maiden Pharma for cough syrup linked deaths in Gambia

DCGI calls out WHO for 'prematurely' blaming Maiden Pharma for cough syrup linked deaths in Gambia

Farhat Nasim16 Dec 2022 6:04 PM IST
"It is clear that perhaps premature deduction was drawn on September 29th itself regarding the cause of death. Every subsequent alert or publication...
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu

Submit Phase IV CT protocol: CDSCO Panel tells Roche over Anti-Cancer drug Pralsetinib

Dr. Divya Colin16 Dec 2022 6:00 PM IST
New Delhi: Reiterating the earlier recommendation regarding the condition of conduct a Phase IV clinical trial of anti-neoplastic drug Pralsetinib,...
CDSCO panel opines Johnson and Johnson to submit details of anticancer drug Teclistamab nod in EU, US

CDSCO panel opines Johnson and Johnson to submit details of anticancer drug Teclistamab nod in EU, US

Roshni Dhar16 Dec 2022 5:20 PM IST
In response to the drug major Johnson & Johnson proposal to import and market Teclistamab sterile liquid in vial 30mg/vial and 90mg/vial, the...
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