Decision on EU marketing authorisation for this population expected by September 2024
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
Heavy bleeding after giving birth is globally a leading cause of death in new mothers
Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision
The agency concluded that for people of all ages, IXCHI should be administered when there is a significant risk of chikungunya infection
It is intended for contrast enhancement in MRI scans
The submission is based on data from the STEP UP and STEP UP T2D clinical trials
Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments
These medicines are essential in preventing RhD immunisation during pregnancy
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
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