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Tag: cdsco

You Searched For "cdsco"
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 Ophthalmic Drug Faricimab

Dr. Divya Colin3 Dec 2022 5:30 PM IST
New Delhi: Suggesting that the protocol title and phase should be revised for India, the Subject Expert Committee (SEC) functional under the Central...
CDSCO nod to Worlds first intra-nasal  COVID vaccine for restricted use

CDSCO nod to World's first intra-nasal COVID vaccine for restricted use

Ruchika Sharma2 Dec 2022 12:00 PM IST
Vaccine is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein.
AstraZeneca Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

CDSCO nod to AstraZeneca Pharma Dapagliflozin tablets

Ruchika Sharma28 Nov 2022 4:30 PM IST
The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded...
CDSCO tells Sandoz to review and report PSUR data of Brolucizumab   injection

CDSCO tells Sandoz to review and report PSUR data of Brolucizumab injection

Dr. Divya Colin27 Nov 2022 1:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug maker...
Akums Drugs & Pharma opens new facility

Akum Pharma gets CDSCO panel nod to manufacture, market antihypertensive FDC drug

Dr. Divya Colin27 Nov 2022 11:45 AM IST
New Delhi: The Subject Expert Committee SEC, functional under the Central Drug Standard Control Organization CDSCO, has approved Akum Pharma to...
GSK Depemokimab applications accepted for review in China, Japan for asthma with type 2 inflammation, CRSwNP

GSK pharma's Mepolizumab to be used on prescription of experienced Registered Medical Specialists: CDSCO Panel

Dr. Divya Colin26 Nov 2022 6:00 PM IST
New Delhi: Approving for the amendment in warning statement for GSK Pharmaceuticals' Mepolizumab 100 mg, the Subject Expert Committee (SEC) functional...
Patient dies from suspected drug reaction to Emcure Pharmas Orofer FCM, Maha FDA issues nationwide recall

Patient dies from suspected drug reaction to Emcure Pharma's Orofer FCM, Maha FDA issues nationwide recall

Farhat Nasim24 Nov 2022 5:48 PM IST
Pune: Drug maker Emcure Pharmaceuticals Ltd. has landed in trouble after a patient at Saifee Hospital administered iron supplement, Orofer FCM (ferric...
Cipla gets CDSCO Panel nod to manufacture, market COPD drug combination Aerosol for inhalation

Cipla gets CDSCO Panel nod to manufacture, market COPD drug combination Aerosol for inhalation

Susmita Roy23 Nov 2022 6:00 PM IST
New Delhi: Granting the phase III clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
GSK Depemokimab applications accepted for review in China, Japan for asthma with type 2 inflammation, CRSwNP

CDSCO panel approves GSK pharma's protocol amendment proposal for Mepolizumab Powder for Solution for Injection

Dr. Divya Colin20 Nov 2022 3:15 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major GSK...
Substandard Drugs Flagged Across Multiple States, Over 130 Batches Fail Quality Tests In April

50 Drug Samples Fail To Qualify CDSCO Test

Susmita Roy17 Nov 2022 5:24 PM IST
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 50 medicine...
Scientific approach followed in Covaxin approval: Govt rebuts all allegations on Bharat Biotech Covaxin hurried approval

Scientific approach followed in Covaxin approval: Govt rebuts all allegations on Bharat Biotech Covaxin hurried approval

Ruchika Sharma17 Nov 2022 3:30 PM IST
New Delhi: There have been media reports claiming that Bharat Biotech, manufacturer of the indigenous COVID-19 vaccine – Covaxin, "had to skip certain...
Dr VG Somani to hold charge of DCGI post for another 3 months

Dr VG Somani to hold charge of DCGI post for another 3 months

Ruchika Sharma16 Nov 2022 5:39 PM IST
Dr Somani was appointed DCGI for a term of three years on August 14, 2019.
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