(Reuters)—An experimental rheumatoid arthritis drug developed by Eli Lilly and Co. and Incyte Corp. poses serious risks of deadly blood clots at higher doses, U.S. Food and Drug Administration staff says, the latest setback to a treatment regulators declined to approve last year. New data provided by the companies in a resubmission of their marketing…
FDA to Review Abuse Deterrent Oxycodone Capsule & More
The FDA will discuss a New Drug Application for Remoxy ER during an upcoming advisory committee meeting and recently approved tildrakizumab-asmn to treat adults with plaque psoriasis…
Dermatology Patients on Corticosteroids May Not Receive Osteoporosis Screenings; Plus FDA Approves ZTLido
A recent study found that dermatology patients taking long-term steroids are not always evaluated for steroid-induced osteoporosis…
Ferumoxytol Injection Receives New Indication, & Application for GP2017 Moves Ahead
The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…
FDA Receives Reports of Loperamide Abuse
The FDA is seeking to limit the number of loperamide doses per package due to reports of heart-related problems and death from the misuse and abuse of the treatment…
New Drug Approvals Hit 21-Year High in 2017
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…
Rheumatology Drug Updates: Hip Fracture Rates After Bisphosphonate Drug Holidays, Plus More on Golimumab, Ustekinumab
Bisphosphonate Drug Holidays Drug holidays are common for patients on bisphosphonate therapy. Often, these breaks in treatment are related to known U.S. Food and Drug Administration (FDA) warnings and drug class adverse effects. Currently, data on fracture risk related to drug holidays are limited. In recent research highlighted at the 2017 ACR/ARHP Annual Meeting ,…
U.S. Approves Digital Pill that Tracks When Patients Take It
(Reuters)—U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.1 The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking…
Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis
Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
Year in Review: The ACR Advances Education, Rheumatic Disease Awareness, Strategic Planning in 2017
It seems like yesterday I was asked to write my first presidential column, and here I am penning my last. It’s incredible how fast the time goes and yet how much gets done. That progress is made possible by the dedicated and talented group of ACR volunteers and staff. This year, the College has had…
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