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

46 News Found

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.


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 approval for oncology biosimilar Bevqolva from UK's MHRA
News | December 22, 2024

CuraTeQ Biologics receives approval for oncology biosimilar Bevqolva from UK's MHRA

Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins


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


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance