Page 2 - Robert Stott News Today

The FDA granted Intercept Pharmaceuticals orphan drug designation for the fixed-dose combination of obeticholic acid and bezafibrate intended for treatment of patients with primary biliary cholangitis. Obeticholic acid (Ocaliva, Intercept Pharmaceuticals) — a farnesoid X receptor agonist — was originally FDA approved for primary biliary cholangitis (PBC) in 2016 in combination with

The FDA has approved AbbVie’s Rinvoq as a once-day pill intended for the treatment of adult patients with moderate to severe Crohn’s disease who are intolerant, or have had an inadequate response, to one or more TNF inhibitors. Upadacitinib (Rinvoq, AbbVie)v is now indicated for both Crohn’s disease and ulcerative colitis. Additionally, this decision marks the drug’s

DESTIN, Fla. — Dermatomyositis and tinea are just two of many dermatologic complications that may resemble rheumatologic conditions, according to a presenter at the 2023 Congress of Clinical Rheumatology-East.

DESTIN, Fla. — Low disease activity and remission are achievable for patients with lupus if clinicians “minimize the prednisone” and administer adequate hydroxychloroquine, noted a speaker at the 2023 Congress of Clinical Rheumatology-East.

Padagis received FDA approval of its abbreviated new drug application for budesonide 2mg rectal foam for the induction of remission in patients with mild to moderate ulcerative colitis, according to a manufacturer release.The FDA has also designated Padagis’ product as a competitive generic therapy, which effectively prevents approval of other ANDAs for this indication for a period of 180

Meridian Bioscience has announced FDA 510(k) clearance of its Curian Shiga Toxin assay intended for detection and differentiation of Shiga toxin 1 and 2 within a single device, according to a company release.By adding Shiga toxin detection, the company has expanded the platform’s foodborne immunofluorescent testing capabilities beyond Campylobacter.

The FDA has issued a warning letter to Olympus Medical over their manufacturing of endoscopes and endoscope accessories following an inspection of their Tokyo facility in Japan. This is the third warning letter from the FDA following two separate letters issued to Olympus at the end of 2022.

A man has been arrested after several members of the public reported that theyd seen an individual carrying a sword near to a hospital in County…

FDA granted fast track designation to Palisade Bio’s broad-spectrum serine protease inhibitor, LB1148, for expedited return of bowel function following gastrointestinal surgery, according to a manufacturer release.Based on prior clinical studies, LB1148 (Palisade Bio) may accelerate the time to the return of normal GI function by reducing the formation of abdominal adhesions. Palisade Bio

PHILADELPHIA — Immunosuppressive or anti-fibrotic drugs do not appear to have any clear impact on worsening gastrointestinal symptoms in patients with early systemic sclerosis, according to data presented at ACR Convergence 2022.