BRIEF-EMA Recommends Change To Product Information For Remdesivir

European Medicines Agency: * EMA- COMMITTEE RECOMMENDED GRANTING CONDITIONAL MARKETING AUTHORISATION FOR ENHERTU FOR TREATMENT OF METASTATIC HER2-POSITIVE BREAST CANCER.

* EMA SAYS RUKOBIA (FOSTEMSAVIR) RECEIVED A POSITIVE OPINION FOR THE TREATMENT OF MULTIDRUG RESISTANT HIV-1 INFECTION * EMA-COMMITTEE RECOMMENDS GRANTING MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES FOR LUMOXITI FOR RELAPSED OR REFRACTORY HAIRY CELL LEUKAEMIA

* EMA - CHMP ADOPTED POSITIVE OPINION RECOMMENDING CHANGE TO PRODUCT INFORMATION FOR REMDESIVIR TO PROVIDE CLEARER INSTRUCTIONS FOR COVID-19 PATIENTS * EMA-CHANGE TO REMDESIVIR COVID-19 INFO NOW ADDS THAT PATIENTS COULD NEED LOW- OR HIGH-FLOW OXYGEN/OTHER NON-INVASIVE VENTILATION AT START OF TREATMENT Source text: (https://bit.ly/3a2Tu79) Further company coverage:

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