FDA News

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). The priority review is based on the positive Phase III MAJESTY results, which show superiority of Gazyva over an immunosuppressive therapy...

VENLO, Netherlands & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the CE-IVDR-certified QIAstat-Dx BCID GN Plus AMR Panel, establishing a comprehensive bloodstream infection testing offering on the QIAstat-Dx platform in Europe. The new QIAstat-Dx BCID GN Plus AMR Panel detects 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance (AMR) markers from positive blood cultures in about one hour. It comp...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the PD‑L1 IHC 28‑8 pharmDx assay as a companion diagnostic to identify patients with esophageal squamous cell carcinoma (ESCC), gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma who may be eligible for treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluronidase‑nvhy), Bristol Myers Squibb’...

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam Awarded New U.S. Patent Expanding Acoustic Sensing and Fluid Monitoring Capabilities of Its Cable-Free ECG Device...

WHITE BEAR LAKE, Minn.--(BUSINESS WIRE)--A.forall announced through its U.S. subsidiary, Milla Pharmaceuticals Inc., that it has received Abbreviated New Drug Application (ANDA) approval by the U.S. Food and Drug Administration (FDA) for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/ 50 mL vials for intravenous use. Sodium Bicarbonate for Injection, USP is indicated as an alkalinizing agent to correct severe metabolic acidosis. The product has intermittently appeared on the FDA Drug shortages l...

LOS ANGELES--(BUSINESS WIRE)--Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that the U.S. Food & Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its proprietary lead small molecule drug candidate NB4168 for the treatment of Ataxia Telangiectasia (A-T). NB4168 is an oral small molecule therapy engineered to deliver substantially greater nicot...

WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today announced a collaboration with Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company, to provide Good Manufacturing Practice (GMP) Next Generation Sequencing (NGS) services for cell characterization. The collaboration helps Arovella achieve its goal of creating a unique Invariant Natural Killer T (iNKT) cell therapy platform for cancer treatment. In a successful IND application, the FDA...

DEL MAR, Calif.--(BUSINESS WIRE)--Sydnexis Announces FDA Advisory Committee Meeting to Review NDA for SYD-101 for Pediatric Progressive Myopia...

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI to launch FDA Registration-Enabling Phase 3 Confirmatory Study to bring Multikine to Market for newly diagnosed head and neck cancer....

LONDON & WARREN, N.J.--(BUSINESS WIRE)--Tenpoint Therapeutics, Ltd., a global commercial ophthalmic pharmaceutical company focused on developing groundbreaking treatments to improve vision in the aging eye, today announced the submission of a Marketing Authorization Application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for the review and approval of YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% – a once-daily, dual-ag...