BioSpace News Archive

Outlook Therapeutics, Inc. (Nasdaq: OTLK), today announced that the U.S. Food and Drug Administration (FDA) has requested additional information in order to complete the filing of the Company’s Biologics License Application (BLA) for ONS-5010/ LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

Stand-alone therapy with PD1 checkpoint inhibitors has shown limited efficacy against ovarian cancer, with response rates in prior clincical trials ranging from 7-15%.

Mesa Laboratories, Inc. announced results for the fourth quarter and full year ended March 31, 2022.

VolitionRx Limited has announced that its Nu.Q® NETs test has been CE marked for the detection and evaluation of NETosis, enabling clinical use in more than 27 countries across Europe.

I-Mab (the “Company”) (Nasdaq: IMAB), today announced the completion of patient enrollment in a Phase 3 clinical trial (TALLER) of highly differentiated long-acting recombinant human growth hormone eftansomatropin alfa (also known as TJ101), which is being investigated as a weekly treatment for pediatric growth hormone deficiency (PGHD) in China.

Edgewise Therapeutics, Inc. announced that members of its senior management team will participate in the following upcoming investor conferences.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that new research and data from its robust oncology portfolio and pipeline of investigational therapies will be presented at the 2022 American Society of Clinical Oncology Annual Meeting, taking place June 3-7 in Chicago, and the European Hematology Association 2022 Congress taking place in Vienna, Austria, June 9-12.

Updated data from Phase 1/2a study show median duration of response greater than 21 months and median progression-free survival of 12 months at 100 mg BID dose.

Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patient care.

Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) cleared its next-generation FreeStyle Libre 3 system for use by people four years and older6 living with diabetes.