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Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the Swiss Agency for Therapeutic Products (Swissmedic) has approved Libmeldy ® (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy, for the treatment of early-onset metachromatic leukodystrophy (MLD).

Akebia Therapeutics, Inc. (Nasdaq: AKBA) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization for Vafseo ® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease.

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that Swissmedic has granted marketing authorization for oral, once-daily ORLADEYO® (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older in Switzerland.

KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, today announced its recently expanded, state-of-the-art Geneva mammalian cell manufacturing facility has obtained a Swissmedic regulatory establishment license.

Moderna, Inc. announced that Swissmedic has granted temporary authorization for the use of Moderna’s Omicron-targeting bivalent booster vaccine, Spikevax Bivalent Original/Omicron for active immunization to prevent SARS-CoV-2 virus-induced Coronavirus-2019 disease for individuals aged 18 years and older.

Novavax, Inc. (Nasdaq: NVAX), today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has expanded its temporary authorization of Nuvaxovid™ (NVX-CoV2373).

Aurinia Pharmaceuticals Inc. announced that the Swiss Agency for Therapeutic Products has granted marketing authorization of LUPKYNIS® in combination with a background immunosuppressive therapy to treat adults with active class III, IV and V lupus nephritis, a serious complication of systemic lupus erythematosus.