and restore the vision of patients with blinding retinal diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to laru-zova (laruparetigene zovaparvovec) for the...
to domestic production. More than 70 percent of the product units Fresenius ships in the U.S. are drugs listed on the FDA’s Essential Medicines List. About Fresenius Kabi: As a global health care company, Fresenius Kabi is Committed to Life. The...
products for clinical trials and commercial use. With our state-of-the-art aseptic plant and strict adherence to GMP and FDA standards, we deliver tailored solutions that guarantee safety, precision, and innovation in every product.
tumors. ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell...
Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for treating liver and intrahepatic bile duct cancer (HCC/ICCA). Achieved in November...
implementing lean operations and compliant quality systems that helped to pave the way for Food and Drug Administration (FDA) approval and the recent acquisition of Axonics by Boston Scientific. Prior to Axonics, Sama was the director of operations...
(sBLA) for less frequent intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024, which was accepted in June 2024. In October 2024, the rolling submission of a Biologics License Application (BLA)...
on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with metastatic de novo or treatment-emergent...
the trial, as we work toward bringing a new therapeutic option to oncology patients." Trial Design and Advancements: The FDA approved the Phase 1a accelerated dose-escalation design based on extensive research, prior clinical testing, and the...
brain disease, announced on the "Neurophet AQUA", has obtained 510(k) clearance from U.S. Food and Drug Administration (FDA) for its newly integrated multiple sclerosis (MS) analysis functionality. The initial clearance, secured in May last year,...
Hanmi obtained approval from both the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) to modify the Phase 1 trial plan to evaluate BH3120 in combination with KEYTRUDA. Full-scale clinical development is...
the clinical potential of this study "Similar to the first gene editing technology-based treatment that received FDA approval last year, I would like to see approval for a treatment based on mitochondrial gene editing technology for mitochondrial...
become a widely available, standardized treatment for a dangerous and potentially fatal condition. As we await potential FDA review and approval, and prepare to launch the LipidRescue Kit, I'm very thankful to the many physicians, researchers,...
Imaging S.p.A., a leading global company in the diagnostic imaging business, is proud to announce that its most recently FDA-approved magnetic resonance imaging (MRI) agent, VUEWAY® (gadopiclenol) solution for injection, has reached over one...
Inc (SystImmune), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and...
approximately 1.5 million people are affected by this condition. Last year, the first treatment for GA was approved by the FDA in the US. However, the drug demonstrated limited efficacy by slowing the progression of GA without restoring previously...
diagnostic in patients with BCR of prostate cancer following a successful end of phase meeting with the U.S. FDA. The trial, named AMPLIFY (64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence...
Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults. COBENFY represents the first new...
EydisBio, Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to EYD-001, its highly selective and potent, orally bioavailable TAK1 inhibitor for the treatment of systemic sclerosis....
center, nuHx, and Marius Pharmaceuticals, the company behind KYZATREX® (testosterone undecanoate) CIII capsules, an FDA-approved oral testosterone treatment for men. Together, they aim to conduct a pioneering study that will measure the impact of...
