BioSpace News Archive

The FDA granted Seagen’s tyrosine kinase inhibitor Tukysa accelerated approval for an aggressive form of colorectal cancer Thursday.

The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.

Disc Medicine inked an exclusive license agreement with Mabwell Therapeutics for the latter’s portfolio of monoclonal antibodies against the TMPRSS6 protein.

Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.

TELA Bio, Inc. announced that the Compensation Committee of the Board of Directors of TELA Bio approved inducement grants of stock options to purchase an aggregate of 4,200 shares of its common stock and restricted stock units covering 7,250 shares of its common stock to 10 newly-hired employees, with a grant date of January 18, 2023.

Passage Bio, Inc., a clinical-stage genetic medicines company focused on developing transformative therapies for central nervous system disorders, announced it has granted an inducement award to a new employee.

Drugmaker Eli Lilly & Co announced today that the FDA has issued a complete response letter, meaning it has not granted accelerated approval for amyloid-clearing antibody donanemab.

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease.

Duality Biologics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression who have progressed on or after standard systemic treatment.

Dr. Reddy’s Laboratories Ltd. announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.