BioSpace News Archive

Today, Alio Inc., announced it received FDA 510(k) clearance for its remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings.

CG Oncology Presents Interim Phase 2 Data with CG0070 in Combination with KEYTRUDA ® (pembrolizumab) in Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin.

LimaCorporate S.p.A., a leading global orthopedic manufacturer focused on digital innovation and tailored hardware, announces that Luigi Ferrari, Chief Executive Officer of LimaCorporate, will be stepping down from the role of CEO, to pursue new activities outside of the organization.

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced the release of its latest generation of Guide Sheath™ Kit, designed to facilitate access to lesions in peripheral regions of the lung via bronchoscopy with radial EBUS.

Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that the U.S. Food and Drug Administration (FDA) has approved Biofrontera Pharma’s cGMP laboratory in Leverkusen, Germany, as a contract laboratory for batch control and stability testing of Ameluz® (aminolevulinic acid hydrochloride gel, 10%).

The U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding on the agency’s previous guidances for industry to improve clinical trial diversity.

Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today the presentation of preclinical data on the company’s anti-CD27 agonist lead antibodies at the American Association for Cancer Research (AACR) Annual Meeting 2022.

APTI has been informed that the first set of claims from US patent application 16/180,960 have been allowed.

AbbVie today announced that the AbbVie Cystic Fibrosis (CF) Scholarship program is now accepting applications for the 2022-2023 academic school year.

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company noted that its Founded Entity, Vedanta Biosciences (“Vedanta”), today announced the publication in the journal Cell Host & Microbe of the results from a Phase 1a/1b study evaluating the safety, tolerability, and colonization dynamics of VE303 in healthy adults.