BioSpace News Archive

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

Arcutis Biotherapeutics, Inc. reported the grant of an aggregate of 58,500 restricted stock units of Arcutis’ common stock to four newly hired employees.

Atara Biotherapeutics, Inc. reported the grant of 3,750 restricted stock units of Atara’s common stock to one newly hired employee.

Dianthus Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, announced that it granted equity awards on April 1, 2024, to six newly-hired, non-executive employees.

Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”) today announced that it will be sharing pipeline updates for all investigational candidates at the upcoming American Association for Cancer Research (“AACR”) Annual Meeting, taking place in San Diego, California from April 5-10, 2024.

Antengene Corporation Limited announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting, taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.

AstraZeneca and Daiichi Sankyo’s ENHERTU® has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

Johnson & Johnson announced that the U.S. FDA has approved CARVYKTI® for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.

Cencora, Inc. (NYSE: COR) today announced that it plans to release its results for the Second Quarter of Fiscal 2024 on Wednesday, May 1, 2024, prior to the opening of trading on the New York Stock Exchange.

PharmAla Biotech Holdings Inc. is pleased to announce that, in another Australian first, its joint venture, Cortexa Pty. Ltd. (“Cortexa”), is proud to have commenced batch manufacturing of GMP LaNeo® MDMA 40mg capsules to support both clinical trials and clinical use under the TGA’s Authorised Prescriber pathway.