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UK approves Janssen COVID-19 Vaccine
europeanpharmaceuticalreview
June 03, 2021
The Janssen COVID-19 Vaccine has been granted conditional marketing authorisation for use in people aged 18 and over in the UK.
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UK approves J&J’s one-dose COVID-19 vaccine
pharmatimes
June 01, 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine.
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EMA, MHRA to review Vertex' Kaftrio for children with CF
pharmatimes
May 21, 2021
The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have validated Vertex' applications to expand the scope of its cystic fibrosis (CF) treatment Kaftrio (ivacaftor/tezacaftor/elexacaftor).
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Astellas’ Xtandi bags additional MHRA approval in prostate cancer
pharmatimes
May 13, 2021
Japanese pharma company Astellas has announced that its prostate cancer therapy Xtandi has gained an approval for an additional indication from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
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MHRA approves label extension for Vertex’s Kaftrio combo
pharmatimes
May 12, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a label extension for Vertex’s cystic fibrosis (CF) treatment Kaftrio in combination with ivacaftor.
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AZ' Tagrisso first to win MHRA approval under Project Orbis
pharmatimes
May 08, 2021
AstraZeneca's Tagrisso (osimertinib), a post-surgery treatment for lung cancer, is the first drug to receive approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis.
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MHRA reports 41 blood clot cases after use of AstraZeneca Covid-19 vaccine
pharmaceutical-technology
May 06, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has reported an additional 41 cases of rare blood clots in people who have received doses of AstraZeneca’s Covid-19 vaccine.
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MHRA authorises Amarin’s heart drug Vazkepa
pharmatimes
April 23, 2021
Amarin’s Vazkepa has received authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment to reduce the risk of cardiovascular (CV) events in high-risk patients.
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New subcutaneous formulation of Tysabri approved in UK
pharmatimes
April 19, 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new subcutaneous (SC) formulation for Biogen’s multiple sclerosis treatment Tysabri.
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Biocon Pharma gets GMP compliance certificate from MHRA, UK
expresspharma
April 13, 2021
Biocon Pharma, a wholly-owned subsidiary of Biocon, has received a certificate of Good Manufacturing Practice (GMP) compliance from the Medicines & Healthcare products Regulatory Agency (MHRA), the United Kingdom (UK), for its manufacturing facility ...