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EMA releases its regulatory strategy for next five years
The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
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European Medicines Agency (EMA)
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FDA and EMA offer updates on COVID-19 treatments and vaccines in development
The FDA and EMA have announced which COVID-19 treatments and vaccines are currently in development, as well as how they are supporting clinical trials.
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EMA advises continued use of hypertension drugs during COVID-19 pandemic
The EMA has said that patients should continue to use angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), despite reports that these worsen COVID-19 infections.
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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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Cabenuva (cabotegravir and rilpivirine) granted approval by Health Canada
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) has been granted by Health Canada, in conjunction with use of Vocabria.
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MEDICRIME – tackling falsified medicines in Europe
In 2014, medicines were stolen from Italian hospitals and resold across Europe. The authors of a new report highlight the flaws in regulations that handed the perpetrators insufficient sanctions and explain why MEDICRIME provides a better regulatory framework.
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Study evaluates if siltuximab benefits COVID-19 patients with respiratory complications
The SISCO study will assess if the anti-IL-6 antibody siltuximab can aid patients suffering Acute Respiratory Distress Syndrome as a complication of the COVID-19 coronavirus.
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EMA issues statement on ibuprofen reports relating to COVID-19
The EMA has announced that reports of NSAIDs like ibuprofen making the COVID-19 coronavirus worse have no scientific basis.
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“Harmonised approach” promoted for COVID-19 treatment clinical trials
The EMA has urged that the research community prioritise large randomised controlled studies for COVID-19 treatments and vaccines.
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EMA begins safety review of ifosfamide cancer medicines
The EMA has announced the results of its pharmacovigilance meeting for March, saying that it has started a review of medicines containing ifosfamide due to a higher risk of encephalopathy.
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EMA offers free advice to COVID-19 vaccine and therapeutic developers
The European Medicines Agency (EMA) announced it will provide free advice to those working on COVID-19 therapeutics and vaccines in the hopes of accelerating approval of a treatment.
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EC grants Orphan Drug Designation to FLT190, a Fabry Disease treatment
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
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EMA announces measures to manage drug shortages as result of COVID-19
An EU Executive Steering Group will discuss how to address the impact of medicine shortages caused due to COVID-19, says the EMA.
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EC grants marketing authorisation to Givlaari® (givosiran) for acute hepatic porphyria
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
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EMA announces update on nitrosamine impurities in medicines
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
