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A disease-modifying osteoarthritis drug (DMOAD) is a disease-modifying drug that would inhibit or even reverse the progression of osteoarthritis. [1] Since the main hallmark of osteoarthritis is cartilage loss, a typical DMOAD would prevent the loss of cartilage and potentially regenerate it.
Regenerative Medicine Advanced Therapy (RMAT) is a designation given by the Food and Drug Administration to drug candidates intended to treat serious or life-threatening conditions under the 21st Century Cures Act. [1] A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. [2]
Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in people unable to tolerate UDCA [2] Epkinly: Treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy [2] Fidanacogene ...
When treatment with DMARDs fails, cyclophosphamide or steroid pulse therapy is often used to stabilise uncontrolled autoimmune disease. Some severe autoimmune diseases are being treated with bone marrow transplants in clinical trials , usually after cyclophosphamide therapy has failed.
The FDA approved AbbVie Inc's (NYSE: ABBV) Rinvoq (upadacitinib; 15 mg) for active psoriatic arthritis (PsA). Like Pfizer Inc's (NYSE: PFE) approval for Xeljanz, Rinvoq's approval also covers ...
The FDA has signed off MoonLake Immunotherapeutics AG's (NASDAQ: MLTX) Phase 2 study of the nanobody sonelokimab in patients with active psoriatic arthritis (PsA). This is a global clinical study ...
Mavrilimumab is a human monoclonal antibody [1] that inhibits human granulocyte macrophage colony-stimulating factor receptor (GM-CSF-R). [2]Mavrilimumab was discovered as CAM-3001 by Cambridge Antibody Technology and is being developed by MedImmune, Inc. [1] as an investigational drug for the treatment of rheumatoid arthritis
Antares Pharma on Monday received the news it hoped to get. The Food and Drug Administration gave a thumbs-up to Otrexup, the company's subcutaneous methotrexate administered via self-injection.