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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 21 Aug 2025
Rhythm Pharmaceuticals announces FDA acceptance of sNDA for setmelanotide in acquired hypothalamic obesity
20 August 2025 - US FDA accepts sNDA for filing with priority review; sets PDUFA goal date of 20 December 2025. ...
Posted by Michael Wonder on 21 Aug 2025
BioAegis Therapeutics awarded second FDA fast track designation for recombinant human gelsolin to treat inflammasome driven decompression sickness
20 August 2025 - Second fast rrack designation in recent months highlights broad potential of rhu-pGSN across multiple diverse inflammation-driven ...
Posted by Michael Wonder on 20 Aug 2025
Izalontamab brengitecan (EGFRxHER3 ADC) granted breakthrough therapy designation by US FDA for patients with previously treated advanced EGFR mutated non-small cell lung cancer
18 August 2025 - First breakthrough therapy designation in the US for SystImmune and Bristol Myers Squibb’s izalontamab brengitecan based ...
Posted by Michael Wonder on 20 Aug 2025
Eylea HD (aflibercept) injection 8 mg applications for expanded US label and pre-filled syringe receive FDA review period extension
20 August 2025 - Regeneron Pharmaceuticals today announced that the US FDA has extended the target action dates to the fourth ...
Posted by Michael Wonder on 20 Aug 2025
Aldeyra Therapeutics receives fast track designation for ADX‑2191 for the treatment of retinitis pigmentosa
19 August 2025 - 025-- Aldeyra Therapeutics today announced that the US FDA has granted fast track designation for ADX-2191 (methotrexate ...
Posted by Michael Wonder on 20 Aug 2025
First of its kind Ozempic listing for kidney disease
19 August 2025 - Regulators have approved Ozempic’s use for kidney disease treatment, opening the door to new combination therapies. ...
Posted 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
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 ...