Entries by BioSpace

Alnylam scores another FDA nod in hATTR

Almost a month ahead of schedule, the U.S. Food and Drug Administration has approved Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults.

,

Novavax delayed again, Moderna’s bivalent vaccine, and more breakthrough cases

A look at some of the latest COVID-19 news includes the U.S. Food and Drug Administration’s plans to review changes to Novavax’s manufacturing process before the regulatory agency authorizes the company’s vaccine. Moderna expects to submit data to regulators soon with expectations of the company’s bivalent COVID-19 vaccine—consisting of the original Spikevax vaccine and a newer version, mRNA-1273.214 that contains an Omicron-specific vaccine—becoming available in late summer.

,

Moderna Makes Headway with COVID-19 Booster, Flu Vaccine

Moderna announced that the company’s Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study. The booster contains the original COVID-19 vaccine, Spikevax, as well as a vaccine targeting the Omicron variant.