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…
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 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…
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…
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