Pharmafile Logo
Pharmafocus logo
Advanced Search

MHRA

Showing 15 posts of 105 posts found.

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 …

News
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 …

News
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 …

News
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 …

News
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 …

News
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 …

News
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 …

News

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 …

News

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 …

News
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, …

News
lilly_entrance_web

Lilly’s cancer drug Retsevmo gets UK approval for multiple indications

March 10, 2021
Research and Development Cancer, Eli Lilly, MHRA

The MHRA has granted conditional marketing authorisation for Eli Lilly’s Retsevmo (selpercatinib) as monotherapy for a number of cancer indications.

News
tukysa

Seagen’s breast cancer drug TUKYSA gets UK approval

February 22, 2021
Sales and Marketing Cancer, MHRA, Seagen

The MHRA has granted marketing authorisation in the UK for Seagen’s TUKYSA (tucatinib) in combination with trastuzumab and capecitabine, for …

News
img_4190-e1376666350337-web

MHRA grants Promising Innovative Medicine Designation to Sanofi’s RSV drug

January 19, 2021
Manufacturing and Production MHRA, Sanofi

The MHRA has granted a Promising Innovative Medicine (PIM) Designation to Sanofi’s nirsevimab, which is being investigated a passive immunisation …

News
img_4190-e1376666350337-web

MHRA warns patients with history of significant allergic reactions not to receive Pfizer/BioNTech COVID-19 vaccine

December 9, 2020
Research and Development COVID-19, MHRA, UK, Vaccine

While the rolling out of Pfizer and BioNTech’s COVID-19 in the UK this week marked a historic moment in a …

News
img_4190-e1376666350337-web

MHRA gives OK to Bavencio for first-line maintenance of advanced bladder cancer via the Early Access to Medicines Scheme

September 3, 2020
Sales and Marketing Bavencio, MHRA, Merck, Pfizer, UK, eams, pharma

It has been revealed that Bavencio (avelumab), jointly developed by Merck KGaA and Pfizer, has been approved by the UK …

News
The Gateway to Local Adoption Series

Latest content

STADA and Bio-Thera’s Gotenfia receives positive CHMP opinion for autoimmune diseases

December 18, 2025

Norgine enters exclusive licensing agreement with Vir Biotechnology

December 18, 2025

Incyclix appoints Kimberly Blackwell to Board of Directors

December 17, 2025

Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

December 17, 2025

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

December 16, 2025