(Reuters)—Ironwood Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration (FDA) approved its oral drug to treat a condition associated with gout. The company’s once-daily drug, Duzallo (lesinurad and allopurinol), was approved to treat hyperuricemia in patients with gout, Ironwood said. Duzallo combines the standard-of-care treatment, allopurinol, with Ironwood’s lesinurad to treat inefficient…
Sirukumab Approval Stalls
Citing safety concerns, the FDA Arthritis Advisory Committee voted against recommending approval of sirukumab for treating adults with RA…
Abatacept Approved for Adult PsA
The FDA has approved abatacept to treat adults with active psoriatic arthritis. In clinical trials, the treatment has proved effective in both intravenous and subcutaneous forms…
U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
WASHINGTON (Reuters)—Republican and Democratic lawmakers on Thursday discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines. The focus at a hearing, held by members of the House Judiciary Committee’s antitrust subcommittee, was on the use by some brand name drug companies of a U.S….
FDA Requests Removal of Opana ER; Plus Abatacept’s New Dosing Option
The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…
News Updates for Diclofenac Sodium, Denosumab & Sarilumab
In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…
FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA
Due to possible heart-related side effects, romosozumab is no longer expected to be approved this year for the treatment of osteoporosis…
NSAIDs Increase MI Risk; Plus New Label Warnings for Canagliflozin
NSAIDs Increase Myocardial Infarction Risk According a recent meta-analysis of real-world non-steroidal anti-inflammatory drug (NSAID) use, NSAIDs may increase the risk of acute myocardial infarction (AMI). The analysis used individual patient data meta-analysis of studies from healthcare databases in Canada, Finland and the U.K. to determine the time course for risk of AMI, as well…
Heart Safety Clouds Hopes for Amgen, UCB Bone Drug Approval
(Reuters)—Amgen Inc. and UCB SA no longer expect their experimental osteoporosis drug to win U.S. approval this year after a higher rate of serious heart-related side effects were observed in a late-stage clinical trial. The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the…
Infliximab-abda Becomes 5th Biosimilar Approved in the U.S. & Abaloparatide Approved for Osteoporosis
The FDA has approved infliximab-abda, a biosimilar for treating multiple rheumatic diseases, as well as abaloparatide for treating postmenopausal women with osteoporosis…
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