MHRA
ViroCell and GOSH gain MHRA manufacturing approval
November 1, 2023Manufacturing 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 …
AbbVie’s Aquipta receives MHRA marketing authorisation
September 5, 2023Sales 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, 2023Medical 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 …
MHRA authorises GSK’s RSV vaccine for older adults
July 10, 2023Medical 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, 2023Medical 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 …
New targeted lung cancer treatment coming to UK under MHRA scheme
July 15, 2021MHRA, NSCLC, UK, brexit
The MHRA has issued an Early Access to Medicines Scheme (EAMS) positive scientific opinion for tepotinib, for the treatment of …
Sickle cell therapy granted innovation passport by MHRA
June 30, 2021Research 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 …
Epilepsy drug receives MHRA marketing authorisation
June 17, 2021MHRA, epilepsy, marketing authorisation
The MHRA has granted marketing authorisation (MA) for Ontozry (cenobamate) for the treatment of focal-onset seizures in adult patients with …
MHRA approves venetoclax as acute myeloid leukemia treatment
June 8, 2021Manufacturing 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 …
MHRA confirms registration of Avacta’s lateral flow test
June 7, 2021Sales 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 …
Vertex applies to expand indication of cystic fibrosis drug
May 20, 2021EMA, MHRA, cystic fibrosis
Vertex has announced that the EMA and MHRA have validated the post marketing applications for an expanded indication of Kaftiro …
Astellas prostate cancer drug gets third approval from MHRA
May 12, 2021Research and Development Astellas, MHRA, cancer research, cancer treatment, pharma, pharma news, prostate cancer
The MHRA has approved Astellas Pharma’s XTANDI (enzalutamide) drug for the treatment of a third form of prostate cancer, making …
MHRA gives green light to new cardiovascular treatment
April 23, 2021Medical Communications MHRA, cardiovascular
The MHRA has granted a Great Britain Marketing Authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce the risk …
MHRA grants marketing authorisation for new formulation of Tysabri
April 16, 2021Medical Communications MHRA
Biogen UK has been granted marketing authorisation by the MHRA for a subcutaneous (SC) injection of Tysabri (natalizumab), for adults …
Novartis MS therapy gains MHRA and EC approval
April 8, 2021European Commission, MHRA, Novartis, pharma, pharma news
The MHRA and European Commission have both granted marketing authorisation to Novartis for its Kesimpta therapy, for the treatment of …
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