MHRA

Showing 15 posts of 95 posts found.

headache

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 …

markus-spiske-dnbtfbnqlrc-unsplash_1

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 …

img_4190-e1376666350337-web

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 …

img_4190-e1376666350337-web

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 …

img_4190-e1376666350337-web

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 …

img_4190-e1376666350337-web

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 …

covid_cell_1_20

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 …

vertex-headquarters

Vertex applies to expand indication of cystic fibrosis drug

May 20, 2021
EMA, MHRA, cystic fibrosis

Vertex has announced that the EMA and MHRA have validated the post marketing applications for an expanded indication of Kaftiro …

MHRA sign

Astellas prostate cancer drug gets third approval from MHRA

May 12, 2021
Research 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 …

img_4190-e1376666350337-web

MHRA gives green light to new cardiovascular treatment

April 23, 2021
Medical 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, 2021
Medical 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, 2021
European 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 …

img_4190-e1376666350337-web

Accord Healthcare launches thalidomide for multiple myeloma treatment

March 23, 2021
Manufacturing and Production MHRA, oncology

Accord Healthcare has announced the UK launch of a generic thalidomide, which is used in combination with melphalan and prednisone, …

Latest content