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Articles tagged with "drug approvals"

FDA Officials Discuss Extrapolation & Confusion Around Pediatric Therapies

Thomas R. Collins  |  December 3, 2024

A session at ACR Convergence 2024 addressed several recent drug approvals in pediatric rheumatology and a safety update for IL-1/IL-6 inhibitors.

FDA Revokes Emergency Use Authorization for Evusheld

From the College  |  February 2, 2023

The Food & Drug Administration announced Jan. 26 that tixagevimab/cilgavimab (Evusheld) is no longer authorized for use in the U.S. The decision was based on new data suggesting that the treatment is unlikely to be active against the most common current SARS-CoV-2 variants.

FDA Officials Speak Out: New Approvals & Safety Concerns Discussed

Thomas R. Collins  |  December 13, 2022

PHILADELPHIA—Officials from the U.S. Food & Drug Administration discussed recent drug approvals and drug safety issues at ACR Convergence in November in a session that captured the flurry of activity in the rheumatology sphere at the agency over the past year. Sabiha Khan, MD, clinical reviewer in the Division of Rheumatology and Transplant Medicine at…

EU Approves Tofacitinib Citrate for 2 Pediatric Conditions

Michele B. Kaufman, PharmD, BCGP  |  September 8, 2021

The European Commission approved tofacitinib citrate to treat two pediatric conditions, as well as a prolonged-release version of the medication designed to treat adults with active PsA.

Health Canada Approves Upadacitinib to Treat Adults with PsA

Michele B. Kaufman, PharmD, BCGP  |  July 6, 2021

Based on data from two phase 3 clinical trials, Health Canada has approved the use of upadacitinib to treat adults with active psoriatic arthritis.

Tainted Research Repeatedly Re-Used to Assess Drug Effectiveness

Gene Emery  |  March 5, 2019

(Reuters Health)—A new study shows how fake news—specifically, information about scientific research that may be tainted by fraud—keeps getting spread through the medical literature, misleading doctors about the safety and effectiveness of the drugs they prescribe. At issue is the failure of medical journals to flag research that’s been identified by the U.S. Food and…

FDA Approves Opioid Treatment

Michele B. Kaufman, PharmD, BCGP  |  November 13, 2018

The FDA has approved the use of sublingual sufentanil (Dsuvia) to treat acute pain in adults in a medically supervised setting…

New Drug Approvals Hit 21-Year High in 2017

Ben Hirschler  |  January 2, 2018

LONDON (Reuters)—U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light—more than double the previous year—while the figure also rose in the European Union. The European Union (EU) recommended 92 new drugs, including generics, up from 81; and China laid out plans to speed up approvals in what…

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