The FDA has approved baricitinib in a 2 mg tablet dose to treat patients with moderate to severe active rheumatoid arthritis…
Certolizumab Pegol Receives FDA Approval for Plaque Psoriasis
On the basis of data from multiple clinical trials, the FDA has approved certolizumab pegol for treating moderate to severe plaque psoriasis…
FDA Approves Denosumab for Glucocorticoid-Induced Osteoporosis
Denosumab is now approved to treat adults with glucocorticoid-induced osteoporosis…
FDA Updates Ixekizumab Label to Include Genital Area Psoriasis
Ixekizumab is the first agent approved by the FDA for treating plaque psoriasis to include labeling for psoriasis in the genital area…
Alendronate May Provide Cardiovascular Benefits; Plus FDA Approves Subcutaneous Tocilizumab
New research has linked alendronate to reduced cardiovascular death in hip fracture patients…
FDA Names Drugmakers Potentially Acting to Delay Cheap Generics
(Reuters)—The U.S. Food and Drug Administration on Thursday listed drugmakers, including Celgene Corp, Johnson & Johnson, Gilead Sciences and Novartis AG, who the regulator says are potentially blocking access to samples of their drugs to delay generic competition. Generic drugmakers may not be able to develop alternatives without access to samples of branded products they…
Drug Safety: Fasinumab Evaluated in Clinical Trials, Plus Celecoxib May Not Pose Increased Heart Attack or Stroke Risk
After an independent review, ongoing clinical trials investigating the safety of fasinumab for treating hip or knee OA will discontinue the use of higher fasinumab doses…
FDA Update: Committee Recommends 2 mg Baricitinib Approval; HLH Identified as Serious Adverse Event for Lamotrigine
The FDA Arthritis Advisory Committee has recommended the approval of 2 mg baricitinib (but not in a 4 mg dose) for treating adults with moderate to severe active RA…
FDA Staff Raises Safety Concerns Over Arthritis Drug Baricitinib
(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…