BioSpace News Archive

Invizyne Technologies, Inc. announced it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission for the sale of its common stock in a firm commitment public offering.

PharmaTher Holdings Ltd. provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024.

Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) has submitted an Orphan Drug Designation (ODD) application to the U.S. Food and Drug Administration (FDA) for crofelemer.

Monogram Orthopaedics Inc. hosted a recorded discussion of features of Monogram’s mBs and mVision technologies with a surgeon panel.

CymaBay Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid.

YS Biopharma Co., Ltd. today issues an official response to the notice of extraordinary meeting of shareholders of YS Biopharma Co., Ltd.

RadioMedix, Inc. and Orano Med announced that the United States Food and Drug Administration has granted Breakthrough Therapy Designation to AlphaMedixTM for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumors who are naïve to peptide receptor radionuclide therapy.

Iambic Therapeutics announced the publication of research in Nature Machine Intelligence showing that its NeuralPLexer technology outperforms other state-of-the art systems in predicting the structure of protein-ligand complexes as well as the conformational changes to these structures from the addition of drug molecules.

Ossium Health announced the appointment of Lauren Barnes to its Board of Directors.

Nuvalent, Inc. today announced the initiation of the Phase 2 portion of ALKOVE-1, its Phase 1/2 clinical trial of NVL-655 for patients with ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors, following alignment with the US Food and Drug Administration (FDA) on a recommended Phase 2 dose (RP2D) of 150 mg once daily (QD).