EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines

9 April 2020 - As part of its health threat plan activated to fight COVID-19, the EMA has finalised and ...

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Global regulators stress need for robust evidence on COVID-19 treatments

9 April 2020 - International regulators have published a report today highlighting their considerations on the development of potential COVID-19 ...

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Bayer launches pre-filled syringe to administer eye medication Eylea in Europe

8 April 2020 - The European Medicines Agency has granted approval for the new Eylea (aflibercept) injection pre-filled syringe.  ...

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Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer

8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial. ...

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Esperion Announces European Commission approval of the Nustendi (bempedoic acid and ezetimibe) tablet for the treatment of hypercholesterolaemia and mixed dyslipidaemia

6 April 2020 - First non-statin, LDL-C lowering combination medicine ever approved in Europe. ...

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Alnylam completes rolling submission of new drug application to the U.S. FDA and submits marketing authorisation application to the EMA for lumasiran for the treatment of primary hyperoxaluria type 1

7 April 2020 - Lumasiran is the first potential therapeutic to demonstrate substantial reduction in urinary oxalate excretion. ...

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Global regulators discuss observational studies of real world data for COVID-19 medicines

7 April 2020 - In a dedicated COVID-19 workshop, organised by the EMA under the umbrella of the International Coalition of ...

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Essential work to combat the COVID-19 pandemic to continue during EMA's Easter break from 9 to 13 April 2020

7 April 2020 - It is EMA's top priority to help save lives during the pandemic by expediting the development ...

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Esperion announces European Commission approval of the Nilemdo (bempedoic acid) tablet for the treatment of hypercholesterolaemia and mixed dyslipidaemia

6 April 2020 - First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in Europe in Almost Two Decades for Indicated Patients. ...

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European Commission approves Takeda’s Alunbrig (brigatinib) as a first-line treatment for ALK+ NSCLC

6 April 2020 - Approval based on positive results from the Phase 3 ALTA-1L trial showing Alunbrig demonstrated superior overall and ...

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EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic

6 April 2020 - The continued availability of medicines, in particular those used for patients with COVID-19, is of critical ...

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Rybelsus (oral semaglutide) approved for the treatment of adults with type 2 diabetes in the EU

4 April 2020 - Novo Nordisk today announced that the European Commission (EC) has granted marketing authorisation for Rybelsus (oral ...

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EMA provides recommendations on compassionate use of remdesivir for COVID-19

3 April 2020 - During an extraordinary virtual meeting held on 2 April 2020, EMA’s CHMP gave recommendations on how ...

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International regulators discuss available knowledge supporting COVID-19 medicine development

3 April 2020 - On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by ...

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Pfizer receives European approval for oncology biosimilar Ruxience (rituximab)

2 April 2020 - Pfizer today announced that the European Commission has approved Ruxience (rituximab), a monoclonal antibody and biosimilar to ...

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