For Immediate Release: June 29, 2023 Today, the U.S. Food and Drug Administration approved Roctavian, an adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A without pre-existing antibodies to adeno- …
For Immediate Release: June 28, 2023 Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is …
For Immediate Release: June 27, 2023 Hoy, la Administración de Alimentos y Medicamentos de Estados Unidos proporciona una actualización sobre su propuesta para crear un Programa de Alimentos Humanos (HFP, por sus siglas en inglés) unificado, que incluye un …
For Immediate Release: June 27, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published new frequently asked questions and additional tools to provide industry with …
For Immediate Release: June 27, 2023 Today, the U.S. Food and Drug Administration is providing an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). These additions …
For Immediate Release: June 23, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued an updated Consumer Update to remind parents about the dangers of accidental …
FDA News Release Agency Recommendations Aim to Inform Psychedelic Drug Development For Immediate Release: June 23, 2023 Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers …
For Immediate Release: June 22, 2023 Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in …
For Immediate Release: June 22, 2023 Today, the U.S. Food and Drug Administration is announcing it has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are …
For Immediate Release: June 20, 2023 Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 …
For Immediate Release: June 20, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA released its report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and …
FDA News Release Pilot Geared Toward Sponsors of Certain Oncology Drug Products Used with Certain In Vitro Diagnostic Tests to Identify Patients for Certain Cancer Treatments For Immediate Release: June 20, 2023 Today, the U.S. Food and Drug Administration …
For Immediate Release: June 16, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted information on its website regarding the formula for COVID-19 vaccines for the 2023 …
For Immediate Release: June 13, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “Accelerating Rare disease Cures (ARC) Program Emerges as a …
For Immediate Release: June 12, 2023 Today, the U.S. Food and Drug Administration issued a draft guidance to help manufacturers and distributors recognize situations that will prevent microbial contamination in tattoo inks. “With about 30 percent of people …
For Immediate Release: October 06, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated its infant formula compliance program for FDA investigators, laboratory …
For Immediate Release: June 09, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided information to health care providers and facilities on oxygenator devices used in …
For Immediate Release: July 06, 2023 Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial …
For Immediate Release: June 06, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued a Letter to Health Care Providers recommending health care facilities and …
For Immediate Release: June 06, 2023 Español Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect …
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