The Medicines and Healthcare Products Regulatory Agency (MHRA)
10-2 Market Towers
1 Nine Elms Lane
London
SW8 5NQ
United Kingdom
Tel: 020-7084-2000
Fax: 020-7084-2353
Website: http://www.mhra.gov.uk/
Email: info@mhra.gsi.gov.uk
22 articles about The Medicines and Healthcare Products Regulatory Agency (MHRA)
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AMO Pharma Announces MHRA Confirmation of CDM1-RS as Approvable Primary Outcome Measure in Myotonic Dystrophy
2/27/2023
AMO Pharma Limited announced that the UK Medicines and Healthcare products Regulatory Agency has confirmed that the Congenital DM1 Rating Scale can be considered an approvable primary outcome measure in clinical trials to develop a treatment for congenital myotonic dystrophy type 1.
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Athenex Announces MHRA Decision on Oral Paclitaxel
1/3/2023
Athenex, Inc. announced that its proprietary Oral Paclitaxel formulation did not receive regulatory approval from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for metastatic breast cancer based solely on CMC issues.
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Rhythm Pharmaceuticals Announces ▼IMCIVREE® (setmelanotide) Granted Marketing Authorization in Great Britain for Treatment of Obesity and Control of Hunger in Bardet-Biedl Syndrome
11/21/2022
Rhythm Pharmaceuticals, Inc. announced that Great Britain’s Medicines & Healthcare products Regulatory Agency has expanded the marketing authorization for IMCIVREE® to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome in adult and pediatric patients 6 years of age and older.
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The U.K's MHRA has granted conditional authorization to Moderna's newest vaccine candidate, making it the first Omicron-specific COVID-19 booster vaccine approved by a regulatory agency.
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MHRA Grants Marketing Authorization for GBT’s Oxbryta® (voxelotor) for Use in Great Britain for the Treatment of Hemolytic Anemia in Patients with Sickle Cell Disease Age 12 Years and Older
7/26/2022
Global Blood Therapeutics, Inc. announced that the Medicines and Healthcare products Regulatory Agency has granted Great Britain marketing authorization for Oxbryta® for the treatment of hemolytic anemia due to sickle cell disease in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.
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UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) Supports Expedited Review of Marketing Authorization Application for Sabizabulin Treatment in Hospitalized COVID-19 Patients
7/25/2022
Veru Inc. announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency considers that the currently available safety and efficacy data will support an expedited review of the marketing authorization application for the Company’s sabizabulin treatment in hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome when the application is submitted.
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The UK Medicines and Healthcare products Regulatory Agency (MHRA), Australian Therapeutic Goods Administration (TGA) and Health Canada approve KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
6/8/2022
Immunocore Holdings plc announces that the United Kingdom’s Medicines and Healthcare products Regulatory Agency, the Therapeutic Goods Administration in Australia and Health Canada have granted marketing authorization for KIMMTRAK® for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
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Editas Medicine snagged Rare Pediatric Disease designation for its experimental beta thalassemia gene therapy, while VBL received Fast Track designation for an ofra-vec combination in ovarian cancer.
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Revolo Biotherapeutics Receives MHRA Approval for Two Phase 2 Clinical Trials of ‘1805 in Autoimmune Diseases in the United Kingdom
2/4/2022
Revolo Biotherapeutics today announced that it has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to commence two Phase 2 clinical trials to evaluate its immune-resetting drug candidate.
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Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives First Authorization in the World
11/4/2021
Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that the United Kingdom Medicines and Healthcare products Regulatory Agency has granted authorization in the United Kingdom for molnupiravir, the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness.
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It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.
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UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis
9/9/2021
Pfizer Inc. announced that the UK Medicines and Healthcare products Regulatory Agency has granted Great Britain marketing authorization for CIBINQO®, an oral, once-daily, Janus kinase 1 inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and over, who are candidates for systemic therapy.
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Sigilon Therapeutics Announces Acceptance of Clinical Trial Application in the UK for SIG-005 for the Treatment of Mucopolysaccharidosis Type I
9/9/2021
Sigilon Therapeutics, Inc. announced that the Medicines and Healthcare Products Regulatory Agency in the United Kingdom has accepted the Company’s Clinical Trial Application for SIG-005 in Mucopolysaccharidosis Type I, a chronic, progressive lysosomal disease.
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Immunocore Announces UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) Accepts Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma
9/8/2021
Immunocore announces that United Kingdom’s Medicines and Healthcare products Regulatory Agency has accepted a Market Authorisation Application seeking the approval of tebentafusp for the treatment of patients with metastatic uveal melanoma.
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Medivir receives regulatory approval from MHRA for phase 1/2a combination study with MIV-818
8/31/2021
Medivir AB announced that the company has received regulatory approval from the British Medicines & Healthcare products Regulatory Agency for its upcoming phase 1/2a combination study with the company's leading candidate drug MIV-818 against liver cancer.
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Hummingbird Bioscience Announces UK MHRA Approval for First-in-Human Phase 1 Trial of HMBD-001 in Advanced Cancers
8/2/2021
Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, announced that the UK Medicines and Healthcare Products Regulatory Agency has approved the clinical trial application to initiate first-in-human phase 1 trial of HMBD-001 in patients with advanced cancers.
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BioCryst Submits Marketing Authorization Application for UK Approval of ORLADEYO™ (berotralstat), an Oral, Once-daily Therapy to Prevent Attacks in Patients with Hereditary Angioedema
3/2/2021
BioCryst Pharmaceuticals, Inc. announced that the company has submitted a marketing authorization application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency seeking approval of ORLADEYO™ for the prevention of recurrent hereditary angioedema attacks in HAE patients 12 years and older.
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Avacta Announces Phase 1 Clinical Trial Authorisation (CTA) for AVA6000 Approved by MHRA
2/18/2021
Approval for phase 1 dose-escalation and expansion study of pre|CISION FAP-activated doxorubicin pro-drug
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Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19
12/2/2020
U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediately
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MHRA Grants HAE Patients Early Access to BioCryst’s Berotralstat in United Kingdom
10/30/2020
BioCryst Pharmaceuticals, Inc. announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted oral, once-daily berotralstat a positive scientific opinion through the Early Access to Medicines Scheme.