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BOUNTIFUL, Utah--(BUSINESS WIRE)--Vy Spine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VyBrate VBR System which is designed for use in both the cervical and thoracolumbar spine for vertebral body replacement surgery. The VyBrate VBR is an innovative device combining the osseointegration properties of the OXPEKK material and the novel OsteoVy lattice structure...

SAN FRANCISCO--(BUSINESS WIRE)--On the occasion of the 44th J.P. Morgan Healthcare Conference in San Francisco, Bayer AG today unveiled the strategic focus for its Pharmaceuticals Division in 2026. Capitalizing on new launch momentum, the company will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio. High-value commercial products and an accelerating modality-rich pipeline across oncology, cardiology, neurology, and immunology have firmly...

SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that today the U.S. Food and Drug Administration (FDA) has extended the review timeline of its supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is April 13, 2026. The extension follows the recent submission of responses requested by the FDA to further characterize the clinical benefit o...

DUBLIN--(BUSINESS WIRE)--The "FDA Recalls Masterclass: Proactive Preparation and Post-Recall Compliance (Jan 21st - Jan 22nd, 2026)" training has been added to ResearchAndMarkets.com's offering. This course will teach how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves th...

SAN FRANCISCO--(BUSINESS WIRE)--Animate Bio reports positive preclinical data showing two AI-designed peptides reduced lung fibrosis & inflammation, with the lead matching nintedanib...

DUBLIN--(BUSINESS WIRE)--The "Mastering DHF, DMR & DHR - Essential FDA Documentation for Medical Devices (February 3, 2026)" training has been added to ResearchAndMarkets.com's offering. Medical device manufacturing is not an easy process. If anything goes wrong, the entire batch of products is at stake. Is there any solution to it? DHF, DMR, and DHR are the three Ds of medical device that needs to be managed carefully. Even though these files serve different purposes, it is essential to un...

BEDFORD, Mass.--(BUSINESS WIRE)--Rejoni, Inc., a clinical-stage company focused on uterine health, today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and formally filed the Premarket Approval (PMA) application for the Juveena Hydrogel System. In its filing notification, FDA stated that the submission contains the information needed to proceed with substantive review. The Juveena Hydrogel System is designed as a temporary spacer to help prevent the f...

RALEIGH, N.C.--(BUSINESS WIRE)--Univo IRB, today’s fastest-growing central institutional review board (IRB), announced it has successfully completed a routine inspection by the U.S. Food and Drug Administration (FDA) with no findings. The outcome exemplifies Univo IRB’s unwavering commitment to protecting research participants and upholding the highest standards of ethical and regulatory oversight in clinical research. “This inspection result reflects our expertise, diligence, and continued foc...

SAN FRANCISCO--(BUSINESS WIRE)--Canine longevity company Loyal announces FDA Center for Veterinary Medicine acceptance of the Target Animal Safety (TAS) section for LOY-002....

BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s supplemental Biologics License Application (sBLA) for ropeginterferon alfa-2b-njft for the treatment of adult patient...