The FDA has accepted a biologics license application for nano-encapsulated sirolimus with pegylated-adricase (NASP), a combination treatment designed to reduce serum uric acid levels in patients with uncontrolled gout.
FDA Approves 2 More Denosumab Biosimilars
The FDA as approved the biosimilar treatments denosumab-nxxp (Bildyos) and denosumab-nxxp (Bilprevda) for all indications of denosumab, their reference product, including osteoporosis in postmenopausal women.
Oral Treatment for PsA Inches Closer to FDA Approval
The FDA will consider a supplemental new drug application for deucravacitinib for the treatment of adults with active psoriatic arthritis based on promising results from clinical trials.
A New Treatment for Fibromyalgia?
The FDA has approved a new drug application for TNX-102 SL (Tonmya), a tablet with 2.8 mg of cyclobenzaprine HCl, after two clinical trials demonstrated the safety and effectiveness of the treatment in adults with fibromyalgia.
New FDA Label Requirements for Opioids
After reviewing data from post-marketing observational studies, the FDA has issued new labeling requirements for opioids with the goal of emphasizing and explaining the risks associated with long-term use.
Biosimilar Update: 2025 Brings More FDA Approvals & Interchangeability
Here is a brief recap of the latest FDA-approved biosimilar agents, highlighting their reference products and interchangeability.
FDA Approves Upadacitinib for GCA
Supported by data in patients with new-onset and relapsing giant cell arteritis (GCA), the FDA approved upadacitinib for the treatment of adults with GCA.
ACR Executive Committee Holds Meetings with Heads of FDA, CMS
As in past administrations, members of the Executive Committee scheduled meetings with leaders of the Food & Drug Administration and Centers for Medicare & Medicaid Services to discuss ACR policy priorities and agency agendas.
Cilnidipine Receives Orphan Drug Status to Treat Systemic Sclerosis
Based on research showing improved signs and symptoms of systemic sclerosis in patients taking cilnidipine vs. placebo, the FDA granted orphan drug designation for the agent.
Nipocalimab Receives Breakthrough Therapy Status for Sjögren’s Disease
Nipocalimab, an investigational monoclonal antibody that blocks FcRn and reduces levels of circulating immunoglobulin G (IgG) antibodies, has received the FDA’s breakthrough therapy designation for the treatment of Sjögren’s disease.
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