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More News! 30 Nov 2022

FDA grants Sensorion Orphan Drug Designation for hearing loss drug

EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease

Dupixent gets EU nod for children with severe atopic dermatitis

Milestone for gene-edited therapy for sickle cell disease

Janssen looks for talquetamab marketing approval

Drug that could be the first and only in Europe to treat rare brain condition recommended for marketing authorization

In Depth 15 Dec 2022

To avoid stagnation, the EU must refine its ATMP regulation

CSL closer to gene therapy treatments for hemophilia B patients in Europe

EMA gives Myrtelle’s Canavan disease gene therapy candidate OD designation 

Positive antibody persistence for vaccine treating mosquito disease

AstraZeneca and Daiichi Sankyo’s Enhertu recommended for approval

More News! 14 Nov 2022

Minoryx and Neuraxpharm form alliance to get rights to new therapy for rare CNS disease