BioSpace News Archive

The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.

The FDA approved Sage and Biogen’s zuranolone Friday as the first oral medication for postpartum depression but declined to approve the application in major depressive disorder.

The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.

Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.

In a lawsuit filed Monday, Nektar Therapeutics accused Eli Lilly of scheming to ensure rezpegaldesleukin would not succeed after acquiring a competing medicine.

Kytopen, a biotechnology company that develops and markets advanced cell engineering solutions, today announced the appointment of Michael Chiu , Ph.D., as Chief Executive Officer.

MCRA, LLC is pleased to announce its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve the SurVeil™ drug-coated balloon (DCB) to treat peripheral artery disease (PAD).

ImmuCell Corporation, a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, expects to report unaudited financial results for the quarter ended June 30, 2023 after the market closes on Thursday, August 10, 2023.

Akoya Biosciences, Inc., The Spatial Biology Company®, announced its financial results for the second quarter ending June 30, 2023.

Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today reported financial results for the three months ended June 30, 2023.