BioSpace News Archive

Cresilon, Inc. (“Cresilon”), a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, announced today it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”) for its proprietary hemostatic gel technology.

New Swiss Office Launches International Effort to Expand the Market for Company’s Breakthrough Floré Custom Probiotics.

Eli Lilly and Company (NYSE: LLY) announced today that it will host a meeting for the investment community on Wednesday, Dec. 15, 2021, from 9 a.m. to 4 p.m., Eastern time.

Paragonix Technologies, the leading hypothermic donor organ preservation provider, announced the first-in-human clinical use of the investigational NRP-DCD Method by the University of Nebraska Medical Center to recover a donor heart and transport it utilizing the Paragonix SherpaPak® System.

Exact Sciences Corp. (NASDAQ: EXAS) today announced that data from the Rx for Positive Node, Endocrine Responsive Breast Cancer, or RxPONDER, trial were published in The New England Journal of Medicine.

SQZ Biotechnologies Company today announced that its China Initiative has been accepted by the Roche Accelerator.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six company-sponsored Epidiolex® (cannabidiol) oral solution presentations, including one late-breaking abstract, will be debuted at the upcoming 2021 American Epilepsy Society (AES) annual meeting, which will be held December 3 to 7, 2021 in Chicago, IL.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the first patient has been dosed in its Phase 1/2 study of UX053, an investigational messenger RNA (mRNA) therapy in development for the treatment of Glycogen Storage Disease Type III (GSDIII).

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).