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Results For "MHRA"

92 News Found

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
Drug Approval | July 17, 2025

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms


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


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


CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA
Drug Approval | April 28, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein


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


Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem
Drug Approval | March 19, 2025

Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem

Alkem Medtech to acquire 100% stake of Bombay Ortho


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.


Venus Remedies secures in-licensing rights from Infex Therapeutics to develop and commercialize MET-X in India
News | February 27, 2025

Venus Remedies secures in-licensing rights from Infex Therapeutics to develop and commercialize MET-X in India

MET-X, a novel metallo-beta-lactamase (MBL) inhibitor, has shown best-in-class performance in preclinical studies


Glenmark Pharma reports Q3 FY25 PAT at Rs. 348 Cr
News | February 17, 2025

Glenmark Pharma reports Q3 FY25 PAT at Rs. 348 Cr

Glenmark’s consolidated revenue was at Rs. 3,387.6 crore as against Rs. 2,506.7 crore recording an increase of 35.1% YoY


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia