International regulators align positions on phase 3 COVID-19 vaccine trials

9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes ...

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Lynparza approved in the EU for BRCA mutated metastatic pancreatic cancer

8 July 2020 - Only PARP inhibitor approved in this disease. ...

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Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU

7 July 2020 - Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective ...

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Launch of public consultation on joint network strategy to 2025

6 July 2020 - EMA and the Heads of Medicines Agencies have developed a joint strategy for the next five ...

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EMA validates and grants accelerated assessment for trastuzumab deruxtecan for the treatment of HER2 positive metastatic breast cancer

6 July 2020 - Daiichi Sankyo today announced that the EMA has validated the marketing authorisation application for trastuzumab deruxtecan, ...

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Oxford University is leading in the vaccine race

2 July 2020 - Governments are pouring money into a more urgent version of the space race. ...

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European Commission approves extended Invokana (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes seen in CREDENCE study

1 July 2020 - The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy ...

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European Commission approves Daurisma (glasdegib) for certain adult patients with newly diagnosed acute myeloid leukaemia

30 June 2020 - Pfizer today announced that the European Commission approved Daurisma (glasdegib), a Hedgehog pathway inhibitor, in combination with ...

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Johnson & Johnson announces European Commission approval for Janssen’s preventive Ebola vaccine

1 July 2020 - This marks the first major regulatory approval of a vaccine developed by Janssen. ...

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Rhythm Pharmaceuticals announces submission of marketing authorization application to the European Medicines Agency for setmelanotide in POMC and LEPR deficiency obesities

1 July 2020 - Company also announces positive data from eight supplemental patients, including four paediatric patients, enrolled in pivotal ...

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International regulators provide guiding principles for COVID-19 clinical trials

1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...

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EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information

30 June 2020 - EMA and the Ministry of Food and Drug Safety of the Republic of Korea have signed ...

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New medicine for cystic fibrosis patients

26 June 2020 - EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Kaftrio, ...

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Samsung Bioepis receives positive CHMP opinion for Aybintio (bevacizumab)

26 June 2020 - Abbintio, a biosimilar candidate referencing Avastin (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for ...

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Daiichi Sankyo provides update on CHMP review of pexidartinib, a CSF1R inhibitor for the treatment of patients with TGCT

26 June 2020 - Daiichi Sankyo today announced that the Committee for Medicinal Products for Human Use of the European Medicines ...

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