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EMA recommends refusal of the marketing authorization for Lagevrio
News | February 25, 2023

EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
Drug Approval | February 20, 2023

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States


USFDA accepts for priority review the sNDA for Merck’s Prevymis
Drug Approval | February 18, 2023

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients


Zydus receives tentative approval from the USFDA for Canagliflozin tablets
Drug Approval | February 16, 2023

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya


FDA approves Pfizer's supplemental new drug application for CIBINQO
Drug Approval | February 14, 2023

FDA approves Pfizer's supplemental new drug application for CIBINQO

Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis


Janssen and Eli Lilly collaboration to address lack of pediatric therapies could rescue mirikizumab program, says GlobalData
News | February 06, 2023

Janssen and Eli Lilly collaboration to address lack of pediatric therapies could rescue mirikizumab program, says GlobalData

The agreement between Eli Lilly and Janssen was established to allow the two companies to share resources for the goal of accelerating the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab).


Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection
Drug Approval | February 02, 2023

Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection

The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities


Moderna announces an investigational respiratory syncytial vaccine mRNA-1345
News | January 23, 2023

Moderna announces an investigational respiratory syncytial vaccine mRNA-1345

mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults


Astellas announces hold lifted by FDA on Fortis clinical trial of AT845
Drug Approval | January 23, 2023

Astellas announces hold lifted by FDA on Fortis clinical trial of AT845

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients