Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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
Ultragenyx initiates rolling submission of niologics license application to US FDA for DTX401 AAV gene therapy for the Treatment of glycogen storage disease type Ia
18 August 2025 - Ultragenyx today announced the initiation of a rolling submission of a niologics license application to the US ...
Posted by Michael Wonder on 19 Aug 2025
Pfizer Canada and BioNTech receive Health Canada approval of LP.8.1 variant adapted COVID-19 vaccine
18 August 2025 - LP.8.1 variant adapted COVID-19 vaccine Cominaty is now authorised in Canada for individuals 6 months of age ...
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 19 Aug 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in Canada for individuals aged 12 and plder
18 August 2025 - Valneva today announced that Health Canada has granted marketing authorisation for its single dose vaccine, Ixchiq, ...
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 18 Aug 2025
Marketing authorisation application for CT001 has been submitted to the EMA for acute pain management in children
14 August 2025 - The marketing authorisation application for CT001 is submitted to the EMA for acute pain management in ...
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
‘National disgrace’: why Australia is still waiting for proton therapy
15 August 2025 - Teddy Marchmont had to go to Florida, and find $360,000, for the best treatment for his brain ...
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 ...