(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…
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…