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Results For "Medicines-and-Healthcare-products-Regulatory-Agency"

51 News Found

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause
Drug Approval | July 11, 2025

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials


Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars
News | July 07, 2025

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone


UK MHRA approves aumolertinib to treat non-small cell lung cancer
Drug Approval | June 05, 2025

UK MHRA approves aumolertinib to treat non-small cell lung cancer

Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor


Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK
News | May 26, 2025

Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK

YESINTEK is indicated for the treatment of adults and children from the age of 6 years and olde


Briefs: Zydus and CuraTeQ Biologics
Drug Approval | May 14, 2025

Briefs: Zydus and CuraTeQ Biologics

CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA


GSK’s blenrep combinations approved by UK MHRA in relapsed/refractory multiple myeloma
News | April 19, 2025

GSK’s blenrep combinations approved by UK MHRA in relapsed/refractory multiple myeloma

Blenrep combinations could redefine treatment as early as first relapse where more effective options are needed


BrePco Biopharma and Piramal Critical Care announce MHRA approval for Neoatricon in UK
Drug Approval | March 21, 2025

BrePco Biopharma and Piramal Critical Care announce MHRA approval for Neoatricon in UK

PCC has secured the commercialization rights for the EU, UK, and Norway and will be responsible for distributing Neoatricon in these regions


RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes


Biocon launches GLP -1, Liraglutide, in UK
News | March 01, 2025

Biocon launches GLP -1, Liraglutide, in UK

The launch follows the approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K.