The FDA is warning that patients with type 2 diabetes taking SGLT2 inhibitors may be at risk of developing a rare, serious infection, Fournier’s gangrene…
EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
FDA Approves Combination Therapy for OA Pain, but Not Duobrii Lotion for Plaque Psoriasis
The FDA has approved a combination of amlodipine and celecoxib, which may lower serum creatinine, for treating osteoarthritis pain and hypertension…
IV Tramadol Promising for Postoperative Pain; FDA Denies IV Meloxicam Approval
In its first phase 3 clinical trial, intravenous tramadol has met its primary endpoint for relieving postoperative pain…
FDA Approves Baricitinib for RA Patients
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…
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