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Results For "European-Union"

214 News Found

Merck receives positive European Union CHMP opinion for Gefapixant
News | July 22, 2023

Merck receives positive European Union CHMP opinion for Gefapixant

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union


EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours
Clinical Trials | October 31, 2025

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1


FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer
Drug Approval | October 23, 2025

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer

The submissions are supported by data from the Phase 3 KEYNOTE-905 trial


Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'
News | September 24, 2025

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women


AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps
News | September 23, 2025

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent


FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease
Drug Approval | September 08, 2025

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD


CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA
News | August 26, 2025

CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA

Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission


Enanta files patent infringement suit against Pfizer
News | August 25, 2025

Enanta files patent infringement suit against Pfizer

The ‘265 Patent is based on Enanta’s July 2020 patent application describing coronavirus protease inhibitors invented by Enanta scientists