Gastrointestinal tract
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
January 27, 2026FDA, Gastrointestinal tract, MRM Health, ulcerative colitis
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational New Drug (IND) clearance from …
Johnson & Johnson submits robotic surgical system for De Novo classification
January 8, 2026Research and Development FDA, Gastrointestinal tract, Johnson & Johnson
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De Novo classification from the US …
Enzybel Pharma 2 and Deebio partner to address pancrelipase shortages
August 15, 2025Manufacturing and Production, Mergers and Acquisitions Deebio, Enzybel Pharma 2, Gastrointestinal tract, Natix, pancrelipase
Enzybel Pharma 2, part of European distributor Natix, has formed an alliance with Chinese enzyme manufacturer Deebio to help alleviate …
Polpharma Biologics and Fresenius Kabi partner to develop treatment for ulcerative colitis and Crohn’s disease
August 5, 2025Mergers and Acquisitions Corporate, Crohn’s disease, Fresenius Kabi, Gastrointestinal tract, Polpharma Biologics, ulcerative colitis
Polpharma Biologics has signed a global licensing agreement with Fresenius Kabi for the commercialisation of PB016, a proposed biosimilar to …
NICE recommends NHS use of mirikizumab for Crohn’s disease
July 11, 2025Medical Communications, Research and Development Crohn’s disease, Gastrointestinal tract, Medicines and Healthcare products Regulatory Agency, NHS, National Institute for Health and Care Excellence (NICE), bowel disease, clinical trial
Eli Lilly (Lilly) has announced that the National Institute for Health and Care Excellence (NICE) has recommended mirikizumab (omvoh) for …
Study into treatment for rare condition in premature infants launches globally
June 9, 2025Research and Development Chiesi Farmaceutici, Elgan Pharma, Gastrointestinal tract, Paediatrics, clinical trial, intestinal malabsorption, premature infant health
Elgan Pharma, specialising in neonatology, and Italy-based biopharma, Chiesi Farmaceutici, have announced the dosing of the first participating infants in …
NICE recommends mirikizumab (Omvoh â–¼) for previously treated moderately to severely active Crohn’s disease 1
May 30, 2025Research and Development Crohn’s disease, Eli Lilly and Company, Gastrointestinal tract, Medicines and Healthcare products Regulatory Agency (MHRA)(, NHS England and Wales, National Institute for Health and Care Excellence (NICE), Omvoh, inflammatory bowel disease (IBD), mirikizumab
In the Phase 3 VIVID-1 trial, patients treated with mirikizumab experienced significant improvement in clinical remission and endoscopic response at …
European Commission approves Johnson & Johnson’s Crohn’s disease therapy
May 12, 2025Market Access, Research and Development, Sales and Marketing Crohn’s disease, European Commission, Gastrointestinal tract, Johnson & Johnson, guselkumab, marketing authorisation
The European Commission (EC) has granted Marketing Authorisation (MA) to Johnson & Johnson’s Tremfya (guselkumab) for the treatment of moderately …
Biomarkers used in trial to prevent systematic onset of Crohns Disease before it begins in Europe-first projectÂ
January 22, 2025Research and Development Crohns Disease, Crohsn, Gastrointestinal tract, Takeda, biomarkers, ibd, project
Takeda, a global biopharmaceutical company, is due to launch a project, INTERCEPT, which will use biomarkers to prevent symptomatic onset …
Ferring demonstrates effectiveness of a treat-to-target approach in mild-to-moderate ulcerative colitis in first major study
October 3, 2024Research and Development Ferring Pharmaceuticals, Gastrointestinal tract, ulcerative colitis
1 October 2024 – Saint-Prex, Switzerland – Ferring Pharmaceuticals today announces results from the OPTIMISE study showing the first real-world …
The National Institute for Health and Care Excellence announce technology appraisal guidance recommending risankizumab for adult patients with moderate to severe ulcerative colitis
August 29, 2024Research and Development AbbVie, Crohns, Gastrointestinal tract, Immunology, NICE, approval, ulcerative colitis
The National Institute for Health and Care Excellence (NICE) have recommended adult patients in England or Wales with moderately or …
New gastric & gastro-oesophageal junction cancer treatment VYLOYâ„¢ â–¼ (zolbetuximab): the first claudin 18.2 biomarker targeted therapy licensed in Great Britain
August 16, 2024GEJ cancers, Gastrointestinal tract, MHRA, Oncology, gastric cancer
Claudin18.2 is an innovative drug-target which is not currently used for any other authorised treatment. There is a large unmet …
FDA release statement exercising caution around dosing errors associated with compounded injectable semaglutide products
July 31, 2024Media Relations, Medical Communications, Pharmacovigilance, US Healthcare & Trade Press FDA, Gastrointestinal tract, compunded injectable, dosage, hospitalisation, pharmaceutical, warning
This week, the US Food and Drug Administration (FDA) and have issued warnings regarding dosing errors associated with compounded injectable …
FDA approves AbbVie’s Skyrizi for UC treatment
June 20, 2024Medical Communications AbbVie, FDA, Gastrointestinal tract, UC, ibd
AbbVie has announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of adult …
AbbVie and FutureGen announce license agreement for IBD therapy
June 14, 2024Research and Development FutureGen, Gastrointestinal tract, ibd, inflammatory bowel disease
AbbVie and FutureGen Biopharmaceutical have announced a license agreement for the development of FG-M701, a next-generation TL1A antibody for the …
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