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RSS FeedPosted by Michael Wonder on 20 Aug 2025
Madrigal receives European Commission approval for Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis
19 August 2025 - Conditional marketing authorisation is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra ...
Posted by Michael Wonder on 20 Aug 2025
Health Canada approves dual immunotherapy Opdivo plus Yervoy for colorectal and liver cancers
19 August 2025 - Bristol Myers Squibb Canada today announced that Health Canada has approved Opdivo (nivolumab) in combination with ...
Posted by Michael Wonder on 20 Aug 2025
Health Canada approves Ozempic to reduce the risk of sustained eGFR decline, end stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
19 August 2025 - Novo Nordisk announced today that Ozempic (semaglutide injection) is now approved as the first and only ...
Posted by Michael Wonder on 20 Aug 2025
PTC Therapeutics receives complete response letter for vatiquinone NDA
19 August 2025 - PTC Therapeutics announced today that the US FDA has issued a complete response letter related to ...
Posted by Michael Wonder on 20 Aug 2025
Altimmune announces FDA fast track designation for pemvidutide in alcohol use disorder
19 August 2025 - Pemvidutide is the only drug currently granted fast track designation in AUD. ...
Posted by Michael Wonder on 19 Aug 2025
NewAmsterdam announces acceptance of marketing authorisation applications for review by EMA for obicetrapib
18 August 2025 - NewAmsterdam Pharma today announced that the EMA has validated the marketing authorisation application for obicetrapib 10 mg ...
Posted by Michael Wonder on 19 Aug 2025
Iovance’s Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma
18 August 2025 - Iovance Biotherapeutics today announced Health Canada has issued a Notice of Compliance with Conditions for Amtagvi ...
Posted by Michael Wonder on 18 Aug 2025
RegenxBio announces FDA review extension of BLA for RGX-121 to treat patients with MPS II
18 August 2025 - RegenxBio today announced that the US FDA extended its review timeline of the biologics license application ...
Posted by Michael Wonder on 18 Aug 2025
Ifinatamab deruxtecan granted breakthrough therapy designation by US FDA for patients with pre-treated extensive stage small cell lung cancer
18 August 2025 - First breakthrough therapy designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based on IDeate-Lung01 phase 2 ...
Posted by Michael Wonder on 18 Aug 2025
Stealth BioTherapeutics resubmits new drug application for elamipretide for the treatment of Barth syndrome
18 August 2025 - Stealth BioTherapeutics today announced the resubmission of a new drug application to the US FDA for Barth ...
Posted by Michael Wonder on 18 Aug 2025
European Commission grants approval of Ogsiveo
18 August 2025 - Merck KGaA announced today that the European Commission granted marketing authorisation for Ogisiveo (nirogacestat), an oral gamma ...
Posted by Michael Wonder on 17 Aug 2025
Wegovy approved in the US for the treatment of MASH
15 August 2025 - Novo Nordisk today announced that the US FDA has approved an additional indication for Wegovy (semaglutide ...
Posted by Michael Wonder on 16 Aug 2025
Vabysmo (faricimab injection) now publicly funded for macular oedema secondary to retinal vein occlusion and pre-filled syringe in Quebec
15 August 2025 - Vabysmo now covered across all three approved indications in the province, providing patients with a comprehensively ...
Posted by Michael Wonder on 16 Aug 2025
MHRA approves teplizumab to delay progression of type 1 diabetes
14 August 2025 - The MHRA has today approved teplizumab (Tzield) to delay the onset of stage 3 type 1 ...
Posted by Michael Wonder on 16 Aug 2025
Tonix Pharmaceuticals announces FDA approval of Tonmya (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia
15 August 2025 - Commercial availability of Tonmya is expected in the fourth quarter. ...