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Results For "MHRA"

88 News Found

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


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals
News | December 31, 2024

Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals

Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million


CuraTeQ Biologics receives positive opinion for biosimilar Zefylti
Drug Approval | December 14, 2024

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti

Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells


Dr. Reddy's launches Toripalimab in India
News | December 01, 2024

Dr. Reddy's launches Toripalimab in India

The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma