(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…
Upadacitinib Receives Breakthrough Designation, Abatacept Use Expands in Australia & More
The FDA has designated upadacitinib a breakthrough therapy to treat adults with moderate to severe atopic dermatitis…
FDA Removes Boxed Warning for Combination Asthma Treatment
Post-market clinical safety trials have indicated that medications containing both long-acting beta agonists (LABAs) and inhaled corticosteroids (ICSs) do not result in more serious asthma-related outcomes than treatment with ICSs alone…
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…
Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA
In the U.S., a new formulation and an ergonomic delivery system for single doses of etanercept are now available for RA patients…
Limbrel Linked to Possible Fatal Adverse Events
The FDA is investigating serious and potentially fatal side effects associated with Limbrel, which is designed to manage metabolic processes in patients with osteoarthritis…