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June 7, 2021

RPK Pharmaceuticals Inc. – 613400 – 06/01/2021

Reference #: #1663 Product: Drugs Recipient: Recipient Name Rich Mangini RPK Pharmaceuticals Inc. 3281 Whipple Rd.Union City, CA 94587United States Issuing Office: Center for Drug Evaluation […]
June 7, 2021

Aducanumab (marketed as Aduhelm) Information

Aduhelm is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. It is approved under the accelerated approval pathway, which provides patients suffering from a serious disease earlier access to […]
June 7, 2021

FDA Grants Accelerated Approval for Alzheimer’s Drug

For Immediate Release: June 07, 2021 Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 […]
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 […]
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