Tag: approval

CAMBRIDGE, Mass., June 18, 2025 (GLOBE NEWSWIRE) --  Biogen Inc. (Nasdaq: BIIB) announced the initiation of dosing in the BRAVE study, a global Phase 3 clinical trial. The BRAVE study will evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia (FA) between the ages of 2 to <16. Both non-ambulatory and ambulatory participants may qualify for the study. Participants will be randomized 2:1 to receive omaveloxolone or placebo once a day for 52 weeks before having the opportunity to move into the open-label extension (OLE). Currently, omaveloxolone is commercialized under the brand name SKYCLARYS^® in over 40 countries, including in the U.S. and the European Union, and is the only approved product for FA in adults and adolescents aged 16 years and older.

COPENHAGEN, Denmark, June 18, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that it has entered into an agreement to sell its Priority Review Voucher (PRV) for a total cash consideration of USD 160 million.

HUNTSVILLE, June 17, 2025 (GLOBE NEWSWIRE) -- This press release has been updated to reflect the correct timing of the funding round.

TORONTO, June 17, 2025 (GLOBE NEWSWIRE) -- Celestica Inc. (NYSE, TSX: CLS), a leader in design, manufacturing and supply chain solutions for the world’s most innovative companies, today announced, in accordance with the requirements of the Toronto Stock Exchange, that the nominees listed in its management information circular were elected as directors of the company at its Annual and Special Meeting of Shareholders held earlier today.