BioSpace News Archive

InDex Pharmaceuticals Holding AB announced that the company has received positive feedback from the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency, regarding the clinical development plan for a future marketing authorization application for the company’s TLR9 agonist cobitolimod, for the treatment of moderate to severe left-sided ulcerative colitis.

EVONETIX LTD, the synthetic biology company bringing semiconductor technology to DNA synthesis, announced the opening of its early access program for semiconductor synthesised DNA.

RIVANNA®, developers of world-first, imaging-based medical solutions, announced the results of a clinical case study demonstrating that Accuro played a crucial role in aiding the placement of an epidural catheter in a parturient with extreme obesity.

Viseon Inc. announced that it has received Quality Management and CE Mark Certification for their MaxView® System device under the new MDR.

CURE Pharmaceutical Holding Corp., a proprietary platform technology company, announced the appointment of former CEO Rob Davidson to Chairman of the Board of Directors.

Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved the Company’s New Drug Application for Epinephrine injection USP, 1 mg/10mL Single Dose Pre-Filled Syringe.

Merck, known as MSD outside the United States and Canada, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA therapies, announced a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology.

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg.

Bio-Path Holdings, Inc., today announced its financial results for the second quarter ended June 30, 2022 and provided an update on recent corporate developments.

Fulcrum Therapeutics, Inc. today announced that management will participate in a fireside chat at the Stifel 2022 Biotech Summer Summit, on Wednesday, August 17, 2022 at 11:30 a.m. ET.