BioSpace News Archive

Analog Pharma (member of Duchesnay Pharmaceutical Group, hereafter “Analog”) and Dipharma S.A. (“Dipharma”) are pleased to announce that their 20 mg nitisinone abbreviated new drug application (ANDA) has received final approval from the U.S. Food and Drug Administration.

Selecta Biosciences, Inc. (NASDAQ: SELB) today announced the presentation of positive data from the Phase 3 DISSOLVE I and DISSOLVE II double-blind, placebo-controlled studies of SEL-212 in patients with chronic refractory gout.

IGM Biosciences, Inc. announced that the U.S. Food and Drug Administration has cleared two Investigational New Drug applications for imvotamab, an IgM-based CD20 X CD3 bispecific antibody T cell engager, enabling the initiation of Phase 1b studies in both severe systemic lupus erythematosus and severe rheumatoid arthritis.

Diality Inc. today announced the appointment of healthcare veteran Robert Funari to its board of directors.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that the company and its research collaborators will present data from 17 studies that highlight the contribution of Guardant blood tests and real-world data to advances in precision oncology and cancer screening at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, June 2-6 in Chicago.

Establishment Labs Holdings Inc. today announced its participation in two upcoming investor conferences.

Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, announced today its first quarter 2023 financial results and provided a business update.

Microbot Medical Inc. announces that an additional milestone was achieved when medical professionals experienced the Company’s LIBERTY Robotic Surgical System as part of a formative study.

Tissue Dynamics, a disruptive AI/ML biopharma company, announced that Prof. Roger D. Kornberg, renowned biochemist and professor of structural biology at Stanford University, will be joining its advisory board.

Nacuity Pharmaceuticals, Inc. today announced that target enrollment of 48 patients has been reached in the SLO-RP Phase 1/2 clinical trial of NPI-001 tablets in patients with retinitis pigmentosa (RP) associated with Usher syndrome (USH).