BioSpace News Archive

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Novavax, Inc. (Nasdaq: NVAX) today announced the European Commission has granted approval for Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older.

Novartis, a global leader in immuno-dermatology and rheumatology, announced today that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults.

Alkermes plc announced that the Registration Statement on Form 10, as amended, filed by Mural Oncology plc was declared effective by the U.S. Securities and Exchange Commission.

CRISPR Therapeutics (Nasdaq: CRSP) today announced the completion of the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee meeting for exagamglogene autotemcel (exa-cel) for the treatment of SCD in people ages 12 and older with recurrent vaso-occlusive crises (VOCs).

STERIS plc announced that the Company will distribute a quarterly interim dividend of $0.52 per share.

Nektar Therapeutics (Nasdaq: NKTR) will announce its financial results for the third quarter 2023 on Tuesday, November 7, 2023, after the close of U.S.-based financial markets.

Apnimed, Inc. announced a new joint venture with Shionogi & Co., Ltd., a leading global research-driven pharmaceutical company based in Japan, to develop novel pharmacologic therapies to treat obstructive sleep apnea and other sleep disorders.

Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in the development of AI-Immunology™ powered vaccines, is pleased to announce initial results from the EVX-01 Phase 2 clinical trial, confirming previous successful Phase 1 findings.

Amarin Corporation plc (NASDAQ:AMRN) today announced the appointment of Jonathan Provoost as the Company’s new Executive Vice President, Chief Legal & Compliance Officer.