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FDA approves Wegovy for MASH with moderate to advanced liver fibrosis
The FDA has approved Wegovy (semaglutide) injection 2.4 mg to treat adults with MASH with moderate to advanced liver scarring (fibrosis),...
Morphic Medical gains CE Mark for RESET endoscopic device
Morphic Medical has received CE (Conformité Européenne) Mark approval for the RESET System, which according to the company is designed to...
First dual GCG/GLP-1ra gains approval from China’s NMPA for chronic weight management
China's National Medical Products Administration (NMPA) has approved Innovent Biologics’ mazdutide, a first-in-class dual glucagon...
FDA approves Soleno’s VYKAT XR to treat hyperphagia in Prader-Willi Syndrome
The FDA has approved Soleno Therapeutics’ VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the...
GT Metabolic expands MagDI System with FDA clearance of 50mm magnet
The FDA has cleared GT Metabolic Solutions’ larger, 50mm MagDISystem magnet to complement the system's existing 40mm magnet. This...
Zepbound (tirzepatide) is the first and only FDA approved prescription medicine for moderate-to-severe OSA in adults with obesity
The FDA has approved Eli Lilly and Company’s Zepbound (tirzepatide) as the first and only prescription medicine for adults with...
GT Metabolic's MagDI System for side-to-side DI anastomosis to "revolutionise industry" after FDA approval
GT Metabolic Solutions has received FDA clearance of its MagDI System for side-to-side duodeno-ileal (DI) anastomosis. The MagDI System...
FDA grants De Novo approval for Distalmotion’s Dexter Surgical Robot for adult inguinal hernia repair
Distalmotion has been granted De Novo approval by the FDA to market the Dexter Surgical Robot for adult inguinal hernia repair. This...
FDA approves Epitomee Capsule for weight management
Epitomee Medical has gained FDA clearance for its Epitomee Capsule, an ingestible medical device designed to support weight management in...
Lilly receives UK marketing authorisation for tirzepatide (Mounjaro) in alternative Kwikpen presentation for two indications
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Eli Lilly’s tirzepatide...
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