FDA News

PARK CITY, Utah & IRVINE, Calif.--(BUSINESS WIRE)--BioSelective Capital Investments and Shayan Enterprises, LLC, a Utah-based risk-capital investment firm, today announced the successful acquisition of BioDuro’s drug product development and manufacturing operations in Irvine, California, resulting in the formation of Forma Life Sciences, Inc. (FORMA), a Delaware corporation established to hold and operate the acquired assets. The transaction includes two highly accredited facilities supporting...

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic Receives FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio...

SAN MATEO, Calif.--(BUSINESS WIRE)--RapidAI, the pioneer of deep clinical AI and global leader in enterprise imaging, today announced details of 28 scientific abstracts accepted at the International Stroke Conference (ISC) 2026, held February 4-6, at the Ernest N. Morial Convention Center in New Orleans. The abstracts span aneurysm monitoring, ischemic stroke detection, advanced imaging visualization, and radiology workflow optimization. Findings reflect the impact of deep clinical AI delivered...

SUNNYVALE, Calif.--(BUSINESS WIRE)--Integrated DNA Technologies on Passage of Medicare Multi-Cancer Early Detection Screening Coverage Act...

WALTHAM, Mass.--(BUSINESS WIRE)--Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AFTX-201, an investigational genetic medicine for the treatment of BAG3 DCM. “We are grateful to the FDA for the timel...

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced preliminary, unaudited fourth quarter and full year 2025 net product revenues for AVMAPKI™ FAKZYNJA™ CO-PACK, business updates, and 2026 priorities. "2025 was a transformative year for Verastem Oncology and the patients we serve. We transitioned to a commercial-stage company with the launch of AVMAPKI FAKZY...

IRVING, Texas--(BUSINESS WIRE)--The 2026 Innovative Technology Exchange will take place in September in Las Vegas during the Vizient Connections Summit. Deadline to apply is April 17...

MELBOURNE, Australia--(BUSINESS WIRE)--Imagion Biosystems, Ltd. announced that the company has lodged an IND application with the FDA for its MagSense® targeted imaging agent....

SEATTLE--(BUSINESS WIRE)--The Seattle facility of AGC Biologics received GMP Certification from Anvisa (Brazil), extending the global reach of AGC Biologics’ customers....

TEL AVIV, Israel--(BUSINESS WIRE)--Endospan, a privately held company pioneering solutions for the endovascular repair of aortic arch disease, today announced the one-year results of their TRIOMPHE Investigational Device Exemption (IDE) Study evaluating the NEXUS® Aortic Arch Stent-Graft System presented during the Society of Thoracic Surgeons (STS) Annual Meeting in New Orleans. TRIOMPHE is a prospective, multicenter, three-arm trial designed to assess the safety and effectiveness of the NEXUS...