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.
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.
FDA Approves Ustekinumab-stba for All Forms & Dosages as Its Reference Product
Ustekinumab-stba (Steqeyma) now has FDA approval for all forms and dosages of its reference product, ustekinumab (Stelara), including a subcutaneous injection to treat pediatric patients with plaque psoriasis or psoriatic arthritis.
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.
FDA Approves Suzetrigine (VX-548), a Non-Opioid Analgesic
Based on research in post-surgery patients, the FDA approved suzetrigine, a non-opioid analgesic, for the treatment moderate to severe, acute pain in adults.
mRNA CAR T Cell Therapy Receives FDA’s Rare Pediatric Designation to Treat Juvenile Dermatomyositis
FDA has granted Descartes-08, an mRNA chimeric antigen receptor T cell therapy, a rare pediatric disease designation for the treatment of juvenile dermatomyositis.
FDA Accepts New Drug Application for Suzetrigine, a Non-Opioid Analgesic
The FDA accepted a new drug application for suzetrigine, a non-opioid analgesic, based on the results from clinical trials in patients with neuropathy and those post-surgery.
FDA Approves 2 Upadacitinib Formulations for Children with pJIA & PsA
Upadacitinib, as a tablet and oral solution, is now FDA approved to treat children age 2 years and older with active polyarticular juvenile idiopathic arthritis or psoriatic arthritis.
FDA Updates Safety & Efficacy Information for Voclosporin
The FDA’s latest label change for voclosporin adds data demonstrating its safety and efficacy, as well as a sustained renal response, in patients with lupus nephritis through three years of treatment.
- 1
- 2
- 3
- …
- 29
- Next Page »