Add this result to my export selection European Pharmacovigilance Risk Assessment Committee (PRAC) concludes that use of remdesivir is not associated with kidney problems Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 12 February 2021 The European Medicines Agency’s PRAC has assessed all available information and concluded there is currently no evidence indicating that reported kidney problems are associated with the use of... Read Summary Type: Medicines Current Awareness (Remove filter) Type: Safety Alerts (Add filter)
Add this result to my export selection EMA organises a second public meeting about the new COVID-19 vaccines Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 23 December 2020 The public meeting, to be held on 8 Jan, will be an opportunity to inform citizens about the approval and use of the new vaccines, to explain how the safety of the vaccines will be assured. Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European Medicines Agency recommends Pfizer/BioNTech COVID-19 vaccine, (Comirnaty®), for conditional authorisation in the EU in people ≥ 16 years Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 21 December 2020 EMA’s scientific opinion paves the way for first marketing authorisation of a COVID-19 vaccine in EU by European Commission with all the safeguards, controls and obligations this entails. Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of licence extension of avelumab (Bavencio) Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 11 December 2020 The licence extension as monotherapy, is for first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of tucatinib (Tukysa) for treatment of HER2-positive locally advanced or metastatic breast cancer Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 11 December 2020 Tucatinib is an oral antineoplastic protein kinase inhibitor of HER2 kinase. Its benefits include increased progression free survival and overall survival including in patients with metastases. Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of potassium citrate / potassium hydrogen carbonate (Sibnayal) for treatment of distal renal tubular acidosis Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 11 December 2020 Available as prolonged-release granules, Sibnayal is an alkalising agent and buffer in metabolic acidosis. It is reported to correct metabolic acidosis in patients with distal renal tubular acidosis. Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of fostemsavir (Rukobia) for treatment of multidrug resistant HIV-1 infection Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 11 December 2020 Fostemsavir is an oral antiviral that selectively inhibits the interaction between HIV and cellular CD4 receptors, thereby preventing viral entry into the host cells. Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of selpercatinib (Retsevmo) for treatment of RET-fusion positive non-small cell lung cancer, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 11 December 2020 Selpercatinib is a RET receptor tyrosine kinase inhibitor, inhibiting wild-type RET receptor tyrosine kinase and multiple mutated isoforms. Reported benefits include objective response rate and... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of moxetumomab pasudotox (Lumoxiti) for treatment of relapsed or refractory hairy cell leukaemia Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 11 December 2020 Moxetumomab pasudotox is a CD22-targeted immunotoxin designed to direct the cytotoxic action of the truncated Pseudomonas exotoxin to cells which express the CD22 receptor. Reported benefits includes... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of fedratinib (Inrebic) for treatment of primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 11 December 2020 Fedratinib is an oral protein kinase inhibitor with antineoplastic activity linked to selective inhibition of the Janus associated kinases. Reported benefits include ability to reduce size of the... Read Summary Type: Medicines Current Awareness (Remove filter)