Roche secures EC approval for Xofluza to treat and prevent influenza in children
The EC approval expands Xofluza’s indication in the EU to include the treatment of uncomplicated influenza and for…
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13 Jan 23
The EC approval expands Xofluza’s indication in the EU to include the treatment of uncomplicated influenza and for…
12 Jan 23
Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol and budesonide, being jointly developed…
09 Jan 23
Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody, indicated as a 100mg/mL intravenous injection, for the…
09 Dec 22
The European Commission (EC) approved Qdenga (TAK-003) for use in individuals aged four years and above, administered subcutaneously…
08 Dec 22
Pfizer has received the FDA’s Prescription Drug User Fee Act (PDUFA) goal date of May 2023, for a…
02 Dec 22
Rezlidhia is an oral, small molecule, indicated for the treatment of adults with relapsed or refractory (R/R) AML…
28 Nov 22
The Taiwan Food and Drug Administration has granted accelerated approval designation (AAD), and South Korea’s Ministry of Food…
24 Nov 22
Skyrizi is a humanised monoclonal antibody inhibitor that selectively targets interleukin-23 (IL-23), a cytokine involved in inflammatory processes,…
23 Nov 22
Hemgenix is a gene therapy that promotes continuous production of factor IX to reduce abnormal bleeding in people…
21 Nov 22
The expanded approval adds new dosing options for Rylaze, which provides sustained asparaginase activity for adult and paediatric…