Brian Park, PharmD

Eplontersen is an investigational ligand-conjugated antisense medicine designed to reduce the production of TTR protein to treat both hereditary and nonhereditary forms of ATTR.

The study evaluated Paxlovid in both vaccinated and unvaccinated patients with COVID-19 at standard risk for progressing to severe disease.

VLX-1005 is a first-in-class, selective small molecule inhibitor of 12-lipoxygenase, a key target within the arachidonic acid pathway.

Amvuttra is a subcutaneously-administered RNAi therapeutic designed to block the production of wild-type and mutant transthyretin protein.

ATX01 is a topical formulation of amitriptyline designed to directly inhibit pain signaling in the nerve fibers on the epidermis and dermis.

The approval is supported by data from a phase 3 study that compared the efficacy, safety, pharmacokinetics and immunogenicity of Riabni to rituximab reference products.

The approval was based upon a bioavailability study in healthy adults comparing baclofen oral tablets to Lyvispah.

The DARE-19 trial evaluated dapagliflozin in addition to standard of care in reducing disease progression, clinical complications and all-cause mortality in 1250 adults hospitalized with COVID-19.