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Results For "European-Commission"

136 News Found

European Commission fines Alchem for participating in API cartel
News | July 05, 2025

European Commission fines Alchem for participating in API cartel

The companies admitted taking part in the cartel in exchange for reduced fines but Alchem did not settle


European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME
Drug Approval | June 28, 2025

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME


Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy
News | June 06, 2025

Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy

Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with Spinal Muscular Atrophy (SMA)


European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease
Drug Approval | March 27, 2025

European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease

EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults


European Commission approves Biocon Biologics' Ustekinumab Biosimilar
News | February 21, 2025

European Commission approves Biocon Biologics' Ustekinumab Biosimilar

YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease


European Commission expands Jemperli plus chemotherapy approval for endometrial cancer
Drug Approval | January 21, 2025

European Commission expands Jemperli plus chemotherapy approval for endometrial cancer

Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show statistically significant and clinically meaningful OS benefit in the overall population


European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors
Drug Approval | November 21, 2024

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept


European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B
Drug Approval | July 26, 2024

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)


European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
Drug Approval | March 13, 2024

European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease

PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally