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Tag: cdsco

You Searched For "cdsco"
USFDA nod to JnJ Tremfya for Crohns disease

J&J Gets CDSCO Panel Nod To Market Teclistamab sterile liquid in Vials

Dr. Divya Colin7 July 2023 6:00 PM IST
New Delhi: In a significant development, the drug major Johnson and Johnson has got approval from the Subject Expert Committee (SEC) functional under...
NPPA fixes Ceiling Price of Dabigatran capsules

NPPA fixes Ceiling Price of Dabigatran capsules

Dr. Divya Colin5 July 2023 6:00 PM IST
New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of the anticoagulant drug...
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

Dr. Reddy's Gets CDSCO Panel Nod To Study Tegoprazan for gastrointestinal diseases

Dr. Divya Colin4 July 2023 6:00 PM IST
New Delhi: The drug major Dr. Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Eris Lifesciences Gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Bisoprolol Fumarate

Eris Lifesciences Gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Bisoprolol Fumarate

Dr. Divya Colin2 July 2023 6:00 PM IST
New Delhi: Granting the waiver of the bioequivalence study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
USFDA grants priority review to Sanofi-Regeneron Dupixent for bullous pemphigoid

CDSCO Panel Approves Sanofi's Protocol Amendment Proposal for SAR443122

Dr. Divya Colin2 July 2023 5:30 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol...
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu

CDSCO Panel Approves Roche's Protocol Amendment Proposal to Study Polatuzumab Vedotin

Dr. Divya Colin2 July 2023 5:15 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment...
Akums Drugs & Pharma opens new facility

Present Rationality for combining FDC: CDSCO panel Tells Akum Pharma on Lobeglitazone, Sitagliptin FDC

Dr. Divya Colin1 July 2023 6:00 PM IST
New Delhi: Regarding the antidiabetic fixed dose combination drug, Lobeglitazone sulfate 0.25mg/0.25mg plus Sitagliptin Phosphate monohydrate...
Bayer Pharma Gets CDSCO Panel Nod To Update Prescribing Information of Anti-cancer Drug Darolutamide

Bayer Pharma Gets CDSCO Panel Nod To Update Prescribing Information of Anti-cancer Drug Darolutamide

Dr. Divya Colin1 July 2023 5:30 PM IST
New Delhi: Bayer Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Boston Scientific FARAPULSE PFA System

Boston Scientific Gets CDSCO Panel Nod for Pivotal Clinical Investigation of MANTIS Clip

Dr. Divya Colin1 July 2023 5:00 PM IST
New Delhi: Boston Scientific has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma

Sun Pharma gets CDSCO Panel nod to study Lumateperone Capsules

Dr. Divya Colin29 Jun 2023 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has granted permission to drug major...
MSN Lab Gets CDSCO Panel Nod To Manufacture, Market  Vigabatrin Powder for Oral Solution

MSN Lab Gets CDSCO Panel Nod To Manufacture, Market Vigabatrin Powder for Oral Solution

Dr. Divya Colin28 Jun 2023 6:00 PM IST
New Delhi: The drug major MSN Laboratories has got approval from the Subject Expert Committee (SEC) functional under Central Drug Standard Control...
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma

Sun Pharma Gets CDSCO Panel Nod to Manufacture, Market Gabapentin for neuropathic pain

Dr. Divya Colin27 Jun 2023 6:00 PM IST
New Delhi: Pharmaceutical major Sun Pharma has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
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