BioSpace News Archive

Drug development can be notoriously slow, and it can take some companies 10 years or more to pass through all the trials and tests required by the Food and Drug Administration.

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today presented initial data from its ongoing Phase 1/2 TRESR clinical trial evaluating camonsertib (RP-3500/RG6526, partnered with Roche).

RapidAI today announced it has received FDA 510(k) clearance for Rapid NCCT Stroke – a major addition to the RapidAI suite of non-contrast based solutions for stroke and trauma care, and the first and only FDA cleared medical device to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.

Ferring to Present Analyses of Data for REBYOTA ™ (fecal microbiota, live – jslm), the First FDA-Approved Microbiome-Based Treatment for the Prevention of Recurrent C. difficile Infection, at DDW 2023.

Precision BioSciences Announces Late-Breaking Abstract of Preclinical In Vivo Gene Editing Research Selected for Oral Presentation at the American Society of Gene & Cell Therapy 26th Annual Meeting.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant360 Response test.

SAB Biotherapeutics (Nasdaq: SABS), (SAB) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains.

Dyadic International, Inc. today announced that the company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 16/640,483, titled “PRODUCTION OF FLU VACCINE IN MYCELIOPHTHORA THERMOPHILA” (the “Patent”), and is expected to provide patent protection through 2038.

Xenocor, creator of the FDA cleared Saberscope, the world’s first true HD, fog-free, articulating, single-use laparoscope, announced a $10 million Series A funding led by GenHenn Venture fund.

Simulations Plus, Inc. today announced that the U.S. FDA has renewed its licenses to the DILIsym ® software platform, the flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI).