BioSpace News Archive

Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the National Medical Products Administration (“NMPA”) in China has granted DANYELZA (naxitamab-gqgk) 40mg/10ml conditional approval.

Oncolytics Biotech® Inc.'s Chinese partner Adlai Nortye announced interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer.

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”) will host a conference call to discuss financial results for its fiscal fourth quarter and full fiscal year ended September 30, 2022, and provide a corporate update, on December 13, 2022 at 4:30 PM Eastern Time.

ARS Pharmaceuticals, Inc., announced that the U.S. Food & Drug Administration (FDA) has accepted its New Drug Application (NDA) for neffy (previously referred to as ARS-1), for the emergency treatment of severe type I allergic reactions in children and adults who weigh 30 kilograms (66 pounds) or more.

CORD, LLC, a privately held ophthalmic medical device company, announced today that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Model SC9 Intraocular Lens (IOL) for the treatment of cataracts.

Fresenius Kabi announced today it has introduced Pralatrexate Injection, a generic equivalent to Folotyn®, for the treatment of relapsed or refractory peripheral T-cell lymphoma.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”) today announced preliminary results from its ongoing potentially pivotal trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM).

The Lung Cancer Research Foundation and the EGFR Resisters, in their second year of a research award partnership, announce the 2022 grant recipients.

Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, today announced it will present late-breaking research at the 2022 San Antonio Breast Cancer Symposium (SABCS) that proves MammaPrint is the first FDA-cleared gene expression profiling test to predict an early-stage breast cancer patient’s benefit from extended endocrine therapy (EET).

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, presented positive safety/tolerability and efficacy data from its lead product candidate, Bria-IMT™, summarized in three poster sessions during the 2022 San Antonio Breast Cancer Symposium® (SABCS).