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February 4, 2021

Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19

Image By: Patrizia Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and Research, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research  The […]
February 4, 2021

Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication – Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine

[Posted 02/04/2021] AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology, Gastroenterology, Cardiology, Oncology  ISSUE: The FDA is alerting the public that preliminary results from a safety clinical trial show […]
February 4, 2021

FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)

[7-26-2019] The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice […]
February 4, 2021

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

FDA previously communicated about the safety clinical trial with Xeljanz, Xeljanz XR (tofacitinib) in February 2019 and July 2019. Drug Safety Communication (PDF – 67KB) 2-4-2021 […]
February 4, 2021

Drug Development Tools | DDTs

DDTs are methods, materials, or measures that can potentially facilitate drug development. FDA established qualification programs to support DDT development. General DDT and Contact Information DDT […]
February 3, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA recomienda no usar lidocaína para el tratamiento del dolor por dentición y requiere nuevo Recuadro de advertencia

Anuncio de seguridad [6-26-2014] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por su sigla en inglés) advirtió que la solución de lidocaína viscosa […]
February 3, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA informa que el psicofármaco ziprasidona (Geodon) está relacionado con reacciones cutáneas poco comunes, pero potencialmente fatales

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte que el fármaco antipsicótico ziprasidona (a la venta con […]
February 3, 2021

Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel Measurement Markings

Summary Company Announcement Date: February 02, 2021 FDA Publish Date: February 03, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaging error resulting in […]
February 3, 2021

FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer

On February 3, 2021, the Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung […]
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