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  • anticancer drug

Tag: anticancer drug

You Searched For "anticancer drug"
Darzalex receives positive EMA Committee opinion for high-risk smouldering multiple myeloma: Janssen-Cilag International

Need More Justification: CDSCO Panel rejects J&J protocol amendment proposal for Teclistamab study

Dr. Divya Colin17 March 2024 5:45 PM IST
New Delhi: Citing that more justification is required, the Subject Expert Committee SEC functional under the Central Drug Standard Control...
CDSCO Panel Asks Glenmark To Justify BE Waiver for FDC Inhalation Suspension With Scientific Evidence

Glenmark Gets CDSCO Panel Nod to Study ISB 2001 in Multiple Myeloma

Dr. Divya Colin28 Feb 2024 6:00 PM IST
New Delhi: The drug major Glenmark has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Intas Gets SEC Nod to Import, Market Anti-Cancer Drug Serplulimab, Phase IV Trial Mandated

Intas Pharma Gets CDSCO Panel Nod to Study anti-cancer Drug Lipid Based Cabazitaxel

Dr. Divya Colin1 Feb 2024 6:00 PM IST
New Delhi: Citing that the firm should include an adequate number of government hospital trial sites, the Subject Expert Committee (SEC) functional...
bms cancer drug dasatinib

CDSCO Panel grants Bristol Myer Squibb's Proposal for Additional Indication of anti-cancer drug Nivolumab

Dr. Divya Colin30 Jan 2024 5:30 PM IST
New Delhi: Noting that sufficient safety data is established, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr Reddys Labs, Alvotech ink pact to codevelop biosimilar candidate to Keytruda

Determine efficacy of immunotherapy in PD-L1 negative and low patients: CDSCO Panel Tells Dr Reddy on Nivolumab

Dr. Divya Colin20 Jan 2024 5:30 PM IST
New Delhi: Based on the Phase I/III clinical trial protocol of the anti-cancer drug Nivolumab presented by the drug major Dr Reddy Laboratories, the...
Recombinant L-Asparginase not approved in India, conduct CT to study:  CDSCO Panel tells Gennova Biopharmaceutical

Recombinant L-Asparginase not approved in India, conduct CT to study: CDSCO Panel tells Gennova Biopharmaceutical

Dr. Divya Colin14 Jan 2024 5:00 PM IST
New Delhi: Highlighting that recombinant L-Asparginase is presently not approved in India, the Subject Expert Committee (SEC) functional under the...
USFDA nod to JnJ Tremfya for Crohns disease

CDSCO Panel grants J&J Protocol Amendment proposal to study anticancer drug Amivantamab and Lazertinib

Dr. Divya Colin9 Jan 2024 5:45 PM IST
New Delhi: Regarding the study of Amivantamab and Lazertinib in combination with platinum-based chemotherapy compared with platinum-based chemotherapy...
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu

Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Giredestrant for Breast Cancer

Dr. Divya Colin7 Jan 2024 6:00 PM IST
New Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Justify inter-subject variability in BE study data: CDSCO Panel Tells Alkem on anticancer drug Relugolix

Justify inter-subject variability in BE study data: CDSCO Panel Tells Alkem on anticancer drug Relugolix

Dr. Divya Colin7 Jan 2024 5:30 PM IST
New Delhi: Reviewing the bioequivalence (BE) study report of the anti-cancer drug Relugolix presented by the drug major Alkem Laboratories, the...
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy

CDSCO Panel Grants Novartis Protocol Amendment Proposal For Alpelisib

Dr. Divya Colin7 Jan 2024 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Expanded age indication for GSK’s AREXVY

Submit Separate Toxicity Data on Indian Subject: CDSCO Panel Tells GSK on BelantamabMafodotin study

Dr. Divya Colin4 Jan 2024 6:00 PM IST
New Delhi: Considering the serious adverse events in the study data (phase-I & II) of Belantamab Mafodotin (GSK2857916) for Injection 100mg...
AstraZeneca Imfinzi approved in EU as immunotherapy for limited stage small cell lung cancer

AstraZeneca Gets CDSCO Panel Nod to Study anticancer drug Volrustomig

Dr. Divya Colin3 Jan 2024 6:00 PM IST
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
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