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

21 News Found

Medherant announces positive Phase 1 results of clinical trial of testosterone patch for women
Clinical Trials | October 29, 2025

Medherant announces positive Phase 1 results of clinical trial of testosterone patch for women

Medherant’s testosterone TEPI Patch could become the first-in-class testosterone patch developed specifically for women


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


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


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


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


Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA
Drug Approval | April 22, 2024

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A


Venus Remedies bolsters its position in oncology space with marketing approval from Philippines, Iraq
Drug Approval | May 10, 2023

Venus Remedies bolsters its position in oncology space with marketing approval from Philippines, Iraq

The company moves a step closer towards achieving its goal of emerging as the top oncology medicine supplier from India in the ASEAN region


Lupin announces successful completion of UK MHRA inspection of Pithampur facilities
Drug Approval | March 27, 2023

Lupin announces successful completion of UK MHRA inspection of Pithampur facilities

With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA