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The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis. 
FDA has approved generic febuxostat 40 mg & 80 mg tabs, for gout - to be made by Read more at Business Medical Dialo

Dr. John Cush RheumNow

7 years 2 months ago
FDA has approved generic febuxostat 40 mg & 80 mg tabs, for gout - to be made by Read more at Business Medical Dialogues: Alembic Pharma gets USFDA nod for generic version of Uloric tablets https://t.co/QpnIoltFEP
The FDA Arthritis Advisory Committee has voted 10-7 in favor of approving the to consider the antifibrotic drug, ninteda

Dr. John Cush RheumNow

7 years 2 months ago
The FDA Arthritis Advisory Committee has voted 10-7 in favor of approving the to consider the antifibrotic drug, nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) https://t.co/UNlpQNJAim
A post hoc analysis of baricitinib use in rheumatoid arthritis (RA) patients shows that while many patients respond well to baricitinib monotherapy or to switching to baricitinib monotherapy, those with less disease control respond well to the addition of methotrexate (MTX) to baricitinb.  
The FDA convened Arthritis Advisory Committee to consider nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) and voted 10-7 in favor of approving the drug for this new indication.
FDA has approved Ruxience (rituximab-pvvr; Pfizer), a biosimilar to Rituxan for use in NHL, CLL, granulomatosis w/ polya

Dr. John Cush RheumNow

7 years 2 months ago
FDA has approved Ruxience (rituximab-pvvr; Pfizer), a biosimilar to Rituxan for use in NHL, CLL, granulomatosis w/ polyangiitis (GPA) & microscopic polyangiitis;(NOT RA) THis is the 2nd RTX biosimilar. https://t.co/GuVG6S980j
Knowing the names of the agents in today’s armamentarium should be simple. But, the nomenclature is notoriously confusing. The names of monoclonal antibodies can stretch to five syllables which defy easy pronunciation beyond the “mab” at the end. Who comes up with these names anyway?
FDA Arthritis Advisory Committee (AAC) and Drug Safety Committees are meeting today in Hyattsville to consider the appro

Dr. John Cush RheumNow

7 years 2 months ago
FDA Arthritis Advisory Committee (AAC) and Drug Safety Committees are meeting today in Hyattsville to consider the approval of nintedanib (OFEV, made by BI), for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) https://t.co/z4uLJ8hdyX
FDA warning about meds that may impair driving (car, bus, train, plane, or boat) - Especially opioids, benzodiazepines,

Dr. John Cush RheumNow

7 years 2 months ago
FDA warning about meds that may impair driving (car, bus, train, plane, or boat) - Especially opioids, benzodiazepines, antidepressants, muscle relaxants, sleep meds, motion sickness & diet pills, ADD or “stay awake” drugs https://t.co/P08wvds0GK
FDA has approved a new biosimilar Hadlima (adalimumab-bwwd), from Samsung Bioepis, for the same indications as Humira (

Dr. John Cush RheumNow

7 years 2 months ago
FDA has approved a new biosimilar Hadlima (adalimumab-bwwd), from Samsung Bioepis, for the same indications as Humira (RA, pJIA, PsA, AS, Crohn’s, UC, plaque psoriasis), but the drug won't be available in the U.S. until June 2023. https://t.co/h4oqwFjR0c
FDA approves generic pregabalin (Lyrica) - for the management of fibromyalgia, neuropathic pain in diabetic neuropathy,

Dr. John Cush RheumNow

7 years 2 months ago
FDA approves generic pregabalin (Lyrica) - for the management of fibromyalgia, neuropathic pain in diabetic neuropathy, and for postherpetic neuralgia or partial onset seizures & neuropathic pain associated with spinal cord injury. https://t.co/Jg5q7LLjT2
The FINCH2 study has shown that filgotinib, an oral once daily JAK 1 inhibitor, is highly effective in rheumatoid arthritis (RA) patients who failed to respond to prior biologic therapy.
EUSTAR Study had 1451 systemic sclerosis (SSc) pts enrolled & 706 had complete data. Predictors of #SSc worsening in

Dr. John Cush RheumNow

7 years 2 months ago
EUSTAR Study had 1451 systemic sclerosis (SSc) pts enrolled & 706 had complete data. Predictors of #SSc worsening included age, active digital ulcers, lung fibrosis, muscle weakness and elevated C-reactive protein level. https://t.co/QepC6I0HLm
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