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June 7, 2021

From Our Perspective

FDA’s Decision to Approve New Treatment for Alzheimer’s Disease By Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research Today FDA approved Aduhelm (aducanumab) […]
June 7, 2021

FDA’s Decision to Approve New Treatment for Alzheimer’s Disease

By Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated […]
June 7, 2021

FDA approves therapy for pediatric patients with serious rare blood disease

FDA has approved Ultomiris (ravulizumab-cwvz) injection to treat patients aged one month and older with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease. PNH is […]
June 7, 2021

Beauty Manufacturing Solutions Corp. – 535116 – 05/27/2021

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Whoojong (Peter) I. Song Recipient Title CEO Beauty Manufacturing Solutions Corp. 1250 Freeport PkwyCoppell, TX […]
June 7, 2021

DDT COA #000151: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Gastroenterology (DG) DDT COA NumberDDT COA #000151 Instrument NameDiary for Irritable Bowel Syndrome Symptoms- […]
June 7, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA aprueba cambios en la etiqueta para el medicamento anticonvulsivo Potiga (ezogabina) que describen el riesgo de anormalidades en la retina, pérdida potencial de la visión y decoloración de la piel

Este informe es una actualización del Comunicado de la FDA sobre la seguridad de los medicamentos: Medicamento anticonvulsivo Potiga (ezogabina) asociado con anormalidades en la retina […]
June 7, 2021

CDERLearn Training and Education

Updated Online Continuing Education Course on FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond FDA’s Center for Drug Evaluation and Research is announcing an […]
June 4, 2021

FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic Disorder

For Immediate Release: June 04, 2021 Today, the U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type […]
June 4, 2021

FDALabel: Full-Text Search of Drug Product Labeling

Overview of FDALabel DatabasePotential UsersWhat is Included in Drug Labeling?Database FeaturesLive Queries   NEW!!Updates and StatisticsUser GuidesReferencesOther ResourcesContact InformationDisclaimer To use FDALabel (version 2.5) select the link below or […]
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