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March 1, 2021

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma

On February 26, 2021, the Food and Drug Administration granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with […]
March 1, 2021

Coronavirus Treatment Acceleration Program (CTAP) Frequently Asked Questions

Consistent with confidentiality restrictions, we report monthly on: Approximate number of therapeutic development programs in the planning stages (i.e., active pre-IND programs), Approximate number of studies […]
March 1, 2021

Rare Disease Day 2021: FDA Shows Sustained Support of Rare Disease Product Development During the Public Health Emergency

Image By: Janet Woodcock, M.D., Acting Commissioner and Janet Maynard, M.D., M.H.S., Director, Office of Orphan Products Development Rare Disease Day is a time to reflect […]
February 26, 2021

La FDA advierte del riesgo de sufrir daños hepáticos graves con los tratamientos de Viekira Pak y Technivie contra la hepatitis C

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) está advirtiendo que los tratamientos de Viekira Pak y Technivie […]
February 26, 2021

La FDA actualiza las etiquetas de los inhibidores del SGLT2 para la diabetes a fin de incluir advertencias sobre concentraciones de ácido demasiado altas en la sangre e infecciones graves del tracto urinario

[12/4/2015] Una reciente evaluación de seguridad realizada por la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) ha llevado […]
February 26, 2021

Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop – 04/09/2021 – 04/09/2021

On This Page Date: April 9, 2021 Time: 1:00 PM – 4:00 PM ET This webinar is FREE. This follow-on webinar will focus on answering attendee […]
February 26, 2021

Public Notification: Vy & Tea contains hidden drug ingredient

[2-26-2021] The Food and Drug Administration is advising consumers not to purchase or use Vy & Tea, a product promoted and sold for weight loss on […]
February 25, 2021

Withdrawn Guidances (Drugs)

Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry 6/1/2028 2/25/2021 Content and Format for Geriatric Labeling 10/05/2001 9/15/2020 Classifying Significant Postmarketing drug […]
February 25, 2021

FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)

Podcast Welcome back to the DISCO, FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
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