MHRA

Showing 15 posts of 96 posts found.

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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, …

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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.

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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 …

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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 …

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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 …

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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 …

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) …

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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 …

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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 …

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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 …

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Medicines recalled after FMD alert

July 1, 2019
Sales and Marketing FMD, MHRA, labels, pharma, recall, supply chain

The MHRA has warned patients that batches of drugs for Parkinson’s, epilepsy and blood clots have been taken out of …

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MHRA recall M&A Pharmachem’s paracetamol due to fungal contamination

June 18, 2019
Manufacturing and Production Contamination, MHRA, fungal, paracetamol, pharma

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall of M&A Pharmachem’s 500mg paracetamol tablets. The …

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MHRA warns of congenital malformation risk of neo-mercazole during pregnancy

February 22, 2019
Medical Communications, Research and Development MHRA, neo-mercazole, pharma

UK drug watchdog The Medicines and Healthcare products Regulatory Agency (MHRA) has warned of the potential side-effects of Neo-mercazole (carbimazole) …

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MHRA issues recall of irbesartan blood pressure meds over carcinogen contamination concerns

January 4, 2019
Manufacturing and Production, Medical Communications MHRA, irbesartan, pharma, sartan, valsartan

Following a number of recalls issued in the US and Europe in the latter half of 2018 for the blood …

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MHRA Chief to step down in 2019

November 21, 2018
Medical Communications, Research and Development MHRA, UK, brexit, pharma

The Medicines and Healthcare products Regulatory Agency (MHRA), the regulator responsible for the efficacy and safety of medicines in the …

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