ACR Convergence 2025| Video: Rheuminations on Milestones & Ageism

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Articles tagged with "FDA"

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff  |  

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…

FDA Panel Backs Amgen Biosimilar of Humira

Toni Clarke  |  

(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…

Rheumatology Drug Updates: Labeling for Fluoroquinolones; FDA to Review Benzhydrocodone/Acetaminophen Combination

  |  

FDA Restricts Fluoroquinolone Use The U.S. Food and Drug Administration (FDA) has twice previously communicated safety information about systemic fluoroquinolones—in August 2013 and July 2008. The safety issues of this medication class described in its latest Drug Safety Communication were also discussed at a November 2015 FDA Advisory Committee meeting.1 The FDA is now advising…

FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira

Reuters Staff  |  

(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…

Rheumatology Drug Updates: Etanercept for Pediatric Plaque Psoriasis

  |  

Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with…

FDA Seeks Suspension of 4,402 Illegal Prescription Drug Websites

Reuters Staff  |  

(Reuters)—The U.S. Food and Drug Administration said on Thursday it, along with international authorities, has formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers. The move is part of a global effort being led by the INTERPOL, the world’s largest police organization, to identify the…

FDA Panel Backs Teva’s Abuse-Resistant Opioid Painkiller

Natalie Grover & Toni Clarke  |  

(Reuters)—A U.S. Food and Drug Administration (FDA) advisory panel recommended approving Teva Pharmaceuticals Industries Ltd’s long-acting opioid painkiller, Vantrela ER, saying data showed it reduces pain and has some abuse-resistant properties. The drug is designed for use every 12 hours for the management of pain severe enough to require around-the-clock treatment in patients who have…