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MHRA

Showing 15 posts of 101 posts found.

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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
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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
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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
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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
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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
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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

MHRA designates cenobamate as a Promising Innovative Medicine for treating drug resistant seizures

August 13, 2020
Research and Development MHRA, cenobamate, seizures

Arvelle Therapeutics has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has given their anti-seizure medication (cenobamate) …

News
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MHRA launches new pharmacovigilance reporting platform for COVID-19 treatments

May 5, 2020
Manufacturing and Production, Research and Development COVID-19, MHRA, UK, coronavirus, pharma

A new online reporting site has been launched by the Medicines and Healthcare products Regulatory Agency’s (MHRA) to track potential …

News
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MHRA expands approval of Dysport for symptomatic treatment of focal spasticity of the upper limbs in paediatric cerebral palsy

January 6, 2020
Sales and Marketing Dysport, MHRA, ipsen, pharma

Ipsen has secured an expansion in the UK to the existing label for Dysport (lemborexant), with the Medicines and Healthcare …

News
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Over half of all US/EU regulator warnings issued to Indian and Chinese manufacturers, report finds

August 28, 2019
Manufacturing and Production, Research and Development China, India, MHRA, UK, manufacturing, pharma

Concerns have been raised concerning the integrity of the global supply chain after a report from The Pharmaceutical Journal revealed …

News

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