MHRA

Showing 15 posts of 101 posts found.

Ascendis Pharma’s Yorvipath approved by MHRA for hypoparathyroidism treatment

April 25, 2024
Medical Communications Ascendis Pharma, Internal Medicine, MHRA, hypoparathyroidism

Ascendis Pharma has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Yorvipath …

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MHRA approves Takeda’s Hyqvia for chronic inflammatory demyelinating polyneuropathy treatment

March 21, 2024
Medical Communications Hyqvia, MHRA, Neurology, Takeda, chronic inflammatory demyelinating polyneuropathy

Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to Hyqvia as a …

MHRA approves GSK’s Omjjara in Great Britain for splenomegaly treatment

January 31, 2024
Medical Communications GSK, MHRA, Omjjara, Oncology, myelofibrosis, splenomegaly

GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation to Omjjara (momelotinib) in …

MHRA approves Mounjaro for diabetes and weight management

January 26, 2024
Medical Communications Diabetes, MHRA, Mounjaro, weight management

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it has approved a four-dose version of the diabetes …

Santhera gains MHRA approval for Agamree as treatment for Duchenne muscular dystrophy

January 12, 2024
Medical Communications Agamree, Duchenne Muscular Dystophy, MHRA, Musculo-skeletal disorder, santhera

Santhera Pharmamceuticals has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Agamree (vamorolone) in the UK …

ViroCell and GOSH gain MHRA manufacturing approval

November 1, 2023
Manufacturing and Production Great Ormand Street Hospital, MHRA, Pharmacy, ViroCell, manufacturing, viral vectors

ViroCell Biologics has announced that it can now manufacture and export viral vectors from Great Ormand Street Hospital’s (GOSH) state-of-the-art …

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AbbVie’s Aquipta receives MHRA marketing authorisation

September 5, 2023
Sales and Marketing AbbVie, Aquipta, MHRA, Neurology, atogepant, migraines

AbbVie has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Aquipta (atogepant), …

Amicus Therapeutics’ Pompe disease treatment approved for use in UK

August 17, 2023
Medical Communications Amicus Therapeutics, MHRA, NICE, Pompe disease, Rare Diseases

Amicus Therapeutics has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorisation …

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MHRA authorises GSK’s RSV vaccine for older adults

July 10, 2023
Medical Communications Arexvy, GSK, Infections and infestations, MHRA, RSV

GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised its Arexvy respiratory syncytial virus (RSV) …

NICE recommends Otsuka’s Lupkynis (voclosporin) in combination treatment for active lupus nephritis

May 4, 2023
Medical Communications MHRA, NICE, Nephrology, Otsuka Pharmaceuticals, lupus nephritis

Otsuka Pharmaceuticals has announced that the National Institutes for Health and Care Excellence (NICE) has recommended Lupkynis (voclosporin) in combination …

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New targeted lung cancer treatment coming to UK under MHRA scheme

July 15, 2021
MHRA, NSCLC, UK, brexit

The MHRA has issued an Early Access to Medicines Scheme (EAMS) positive scientific opinion for tepotinib, for the treatment of …

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Sickle cell therapy granted innovation passport by MHRA

June 30, 2021
Research and Development MHRA, SCD, brexit

Bluebird bio has been granted an innovation passport, under the new UK approval process, for LentiGlobin (bb1111) a promising treatment …

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Epilepsy drug receives MHRA marketing authorisation

June 17, 2021
MHRA, epilepsy, marketing authorisation

The MHRA has granted marketing authorisation (MA) for Ontozry (cenobamate) for the treatment of focal-onset seizures in adult patients with …

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MHRA approves venetoclax as acute myeloid leukemia treatment

June 8, 2021
Manufacturing and Production EC, EU, MHRA, leukemia

The MHRA has announced its approval for AbbVie’s venetoclax, in combination with a hypomethylating agent, for the treatment of newly …

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MHRA confirms registration of Avacta’s lateral flow test

June 7, 2021
Sales and Marketing COVID-19, EU, MHRA, lateral flow test

Avacta has announced that the MHRA has confirmed registration of the AffiDX SARS-CoV-2 antigen lateral flow test, which allows the …

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