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  • copd drug

Tag: copd drug

You Searched For "copd drug"
Zydus Told to Withdraw Unmarketed Strengths, Conduct Phase IV Trial for Approved Combinations Only

Zydus Healthcare gets CDSCO Panel nod to conduct Phase III CT of Glycopyrrolate plus Indacaterol Metered Dose Inhalation

Dr. Divya Colin13 April 2025 6:15 PM IST
New Delhi: The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has granted approval to Zydus...
Zydus Healthcare Gets CDSCO Panel Nod To study Vilanterol plus Umeclidinium powder for inhalation

Zydus Healthcare Gets CDSCO Panel Nod To study Vilanterol plus Umeclidinium powder for inhalation

Dr. Divya Colin9 April 2025 6:00 PM IST
New Delhi: Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Zydus Told to Withdraw Unmarketed Strengths, Conduct Phase IV Trial for Approved Combinations Only

Submit active controlled CT design for moderate to very severe COPD patients: CDSCO Panel tells Zydus Healthcare on Revefenacin inhalation

Dr. Divya Colin16 Nov 2024 6:00 PM IST
New Delhi: Responding to Zydus Healthcare's proposal to manufacture and market Revefenacin Inhalation Solution 175 mcg/3ml, the Subject Expert...
AstraZeneca Imfinzi recommended for approval in EU for adults with muscle-invasive bladder cancer

AstraZeneca gets CDSCO Panel nod to study Budesonide, Glycopyrronium and Formoterol Fumarate

Dr. Divya Colin20 Oct 2024 5:45 PM IST
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
AstraZeneca Breztri met primary endpoints in Phase III trials in asthma

CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal for Tozorakimab Study

Dr. Divya Colin13 Oct 2024 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca's...
AstraZeneca Breztri met primary endpoints in Phase III trials in asthma

CDSCO Panel Approves AstraZeneca's Protocol Amendment proposal for COPD drug Tozorakimab

Dr. Divya Colin5 Sept 2024 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the clinical trial...
AstraZeneca Breztri met primary endpoints in Phase III trials in asthma

CDSCO Panel Approves AstraZeneca's protocol amendment proposal for COPD drug Tozorakimab

Dr. Divya Colin19 Aug 2024 5:45 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Conduct BE study: CDSCO Panel Tells Sun Pharma Labs on COPD drug Umeclidinium powder for inhalation

Conduct BE study: CDSCO Panel Tells Sun Pharma Labs on COPD drug Umeclidinium powder for inhalation

Dr. Divya Colin31 May 2024 6:00 PM IST
New Delhi: In line with the proposal to manufacture and market Umeclidinium powder for inhalation 62.5mcg, the Subject Expert Committee (SEC)...
AstraZeneca Imfinzi recommended for approval in EU for adults with muscle-invasive bladder cancer

CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal For COPD Drug Study

Dr. Divya Colin5 April 2024 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
CDSCO Panel Approves Fabrazyme Label Update, Asks Sanofi to Submit EMA Nod

Sanofi Gets CDSCO Panel Nod to Study COPD drug Itepekimab

Dr. Divya Colin26 Feb 2024 6:00 PM IST
New Delhi: The drug major Sanofi has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Clears Sanofis Updated Myozyme Insert, Seeks Revision on Administration Guidance

CDSCO Panel Approves Sanofi's Protocol Amendment proposal for COPD drug Itepekimab

Dr. Divya Colin21 Jan 2024 5:00 PM IST
New Delhi: The Subject Expert Panel (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Sanofi's...
Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation

Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation

Dr. Divya Colin22 Dec 2023 6:00 PM IST
New Delhi: Rejecting the clinical trial waiver proposal, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
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