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May 28, 2020
Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody.
The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.
May 18, 2020
The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.
The International Coalition of Medicines Regulatory Authorities held a virtual meeting of regulators from around the world to discuss policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic.
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met on May 13, 2020 to discuss measures the European Union is taking to ensure the availability of medicines during the COVID-19 pandemic.
May 14, 2020
The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.
May 07, 2020
A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.
May 06, 2020
EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.
May 02, 2020
Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
EMA’s strategy for regulatory science has divided opinion amongst various industry bodies.