FDA News

FT. LAUDERDALE, Fla.--(BUSINESS WIRE)--Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner’s Booklets/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems (collectively, the “Products”) distributed in the United States, United Kingdom, Mexico, Australia, and the Caribbean. Trividia is updating the E-5 Error Code in the “Messages” section of...

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therap...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s supplemental Biologics License Application (sBLA) for HYMPAVZI® (marstacimab) to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. In the U.S., HYMPAVZI is currently approv...

CLEVELAND--(BUSINESS WIRE)--Cleveland Diagnostics Names Jack Kenny as Chairman of the Board...

PARSIPPANY, N.J.--(BUSINESS WIRE)--IBSA USA, the U.S. subsidiary of the Swiss pharmaceutical company IBSA, announced today that the Food and Drug Administration (FDA) has approved VYBRIQUE™, the first sildenafil oral film available to treat men aged 18 years and older with erectile dysfunction. Erectile dysfunction (ED) impacts an estimated 30 to 50 million men in the U.S. and becomes more prevalent with age. However, ED is not limited to older populations; cases among younger men are on the ri...

CINCINNATI--(BUSINESS WIRE)--Eyas Medical Imaging, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ascent3T™ Neonatal Magnetic Resonance Imaging (MRI) System, a whole-body magnetic resonance scanner designed and optimized specifically for neonate and infant anatomy, including head, body, and extremities. “510(k) clearance marks a significant milestone for the company and reflects our mission to enable healthcare professionals to save more babies’ lives with st...

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...