BioSpace News Archive

VBI Vaccines Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older.

Werewolf Therapeutics, Inc. today announced the Company will present preclinical data demonstrating interleukin-12 (IL-12) and interferon-α (IFNα) INDUKINE TM molecules inhibited syngeneic lymphoma tumor growth in mice, induced anti-tumor immune responses and were tolerated in non-human primates.

BeyondSpring Pharmaceuticals (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN).

Insightec, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today that the Exablate Prostate system received FDA 510K clearance for treating prostate tissue with high intensity Focused Ultrasound.

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) will present new breast cancer research data across its DXd ADC portfolio at the 2021 San Antonio Breast Cancer Symposium (#SABCS21) to be held December 7 to 10, 2021.

Edesa Biotech, Inc. today announced that it has completed enrollment of more than 75% of the patients planned for the primary cohort of a Phase 2b clinical study evaluating the company’s drug candidate, designated EB01, as a monotherapy for chronic allergic contact dermatitis.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced the results from its study to evaluate the immunogenicity and viral load reduction impact of its SARS-CoV-2 vaccine candidate in a hamster challenge study.

Sensus Healthcare, Inc., a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces the signing of an exclusive U.S. distribution agreement with Mattioli Eng.

POINT Biopharma Global Inc., a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, announced changes to its senior leadership team as well as its Board of Directors.

GlaxoSmithKline plc launched Target the Future, an international, multi-year initiative dedicated to advancing innovation and addressing key needs in the multiple myeloma community.