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2285 News Found

mRNA-4157/V940in combination with Keytruda receives PRIME scheme designation from EMA
Drug Approval | April 07, 2023

mRNA-4157/V940in combination with Keytruda receives PRIME scheme designation from EMA

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma


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.


Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Drug Approval | February 25, 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma


Dr. Reddy’s acquires trademark rights of breast cancer drug PRIMCYV from Pfizer
News | January 14, 2023

Dr. Reddy’s acquires trademark rights of breast cancer drug PRIMCYV from Pfizer

Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA


Takeda launches CINRYZE in India for hereditary angioedema patients
News | December 15, 2022

Takeda launches CINRYZE in India for hereditary angioedema patients

CINRYZE is plasma-derived C1-I NH approved for routine prevention (prophylaxis), short-term prevention or pre-procedure prevention, and acute attacks of HAE.


Global pacemakers market set to grow at 5.4% CAGR over next 3 years: GlobalData
News | December 12, 2022

Global pacemakers market set to grow at 5.4% CAGR over next 3 years: GlobalData

GlobalData predicts the average prices of dual chamber pacemakers in both India and China are expected to reduce at an average CAGR of -3.42% from 2022 to 2025.


Merck to present data from Its hematology portfolio ASH meeting
News | December 05, 2022

Merck to present data from Its hematology portfolio ASH meeting

Presentations include new data on investigational medicines – favezelimab (MK-4280), zilovertamab vedotin (MK-2140) and nemtabrutinib – as well as KEYTRUDA (pembrolizumab) in multiple blood cancers


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


Stelis receives recommendation from EMA granting market authorization for Kauliv
Drug Approval | November 14, 2022

Stelis receives recommendation from EMA granting market authorization for Kauliv

Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.