Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 27 Jun 2025
Sephience (sepiapterin) granted marketing authorisation by the European Commission for the treatment of children and adults living with phenylketonuria
23 June 2025 - Launch to be initiated in Germany. ...
Posted by Michael Wonder on 27 Jun 2025
Achieve Life Sciences announces submission of NDA to FDA for cytisinicline as a treatment of nicotine dependence for smoking cessation
26 June 2025 - More than 2,000 clinical trial participants contributed to the body of evidence submitted in the new drug ...
Posted by Michael Wonder on 27 Jun 2025
Xtandi (enzalutamide) now funded in Ontario for all approved prostate cancer indications
26 June 2025 - Today, Astellas Pharma Canada announced that Xtandi (enzalutamide) is now funded by the Ontario Drug Benefit Program ...
Posted by Michael Wonder on 27 Jun 2025
Philogen provides update on marketing authorisation application for Nidlegy in the European Union
24 June 2025 - Philogen today announced the decision to voluntarily withdraw the application for marketing authorisation to the EMA ...
Posted by Michael Wonder on 26 Jun 2025
Grace Therapeutics announces submission of new drug application to US FDA for GTx-104
25 June 2025 - Comprehensive data package includes positive results from Phase 3 STRIVE-ON safety trial of GTx-104. ...
Posted by Michael Wonder on 26 Jun 2025
Precision BioSciences receives FDA rare paediatric disease designation for PBGENE-DMD for the treatment of Duchenne muscular dystrophy
25 June 2025 - Precision BioSciences today announced that the US FDA has granted rare paediatric disease designation for PBGENE-DMD for ...
Posted by Michael Wonder on 26 Jun 2025
BeOne Medicines receives positive CHMP opinion for tablet formulation of Brukinsa
25 June 2025 - BeOne Medicines today announced that the CHMP of the EMA issued a positive opinion recommending approval ...
Posted by Michael Wonder on 26 Jun 2025
FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support diagnosis of Alzheimer’s disease in patients
25 June 2025 - Eli Lilly announced that the US FDA has approved a label update for Amyvid (florbetapir F ...
Posted by Michael Wonder on 26 Jun 2025
FDA grants RMAT designation for enGene’s detalimogene, enabling potential for expedited review in high risk, non-muscle invasive bladder cancer
25 June 2025 - enGene Holdings today announced that the US FDA has granted regenerative medicine advanced therapy designation to detalimogene ...
Posted by Michael Wonder on 25 Jun 2025
After 9 year wait, Boehringer’s IPF drug Ofev faces generic threat weeks into Korea launch
24 June 2025 - Just two months after German pharma Boehringer Ingelheim secured long-delayed reimbursement for Ofev in Korea, generics ...
Posted by Michael Wonder on 25 Jun 2025
Novadip receives RMAT designation for NVD003, its regenerative treatment for congenital pseudarthosis of the tibia
23 June 2025 - Novadip Biosciences is developing NVD003, an autologous therapy derived from adipose stem cells, as a potential ...
Posted by Michael Wonder on 25 Jun 2025
Quoin Pharmaceuticals announces FDA grants rare paediatric disease designation for QRX003 in Netherton syndrome
24 June 2025 - Quoin Pharmaceuticals today announced that the US FDA has granted rare paediatric disease designation for the ...
Posted by Michael Wonder on 25 Jun 2025
Linerixibat accepted for review by the EMA for cholestatic pruritus in patients with primary biliary cholangitis
23 June 2025 - Submission based on data from positive GLISTEN Phase 3 trial ...
Posted by Michael Wonder on 25 Jun 2025
Syndax announces FDA priority review of sNDA for Revuforj (revumenib) in relapsed or refractory mNPM1 acute myeloid leukaemia
24 June 2025 - Syndax Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental new drug ...
Posted by Michael Wonder on 25 Jun 2025
FDA approves Benlysta (belimumab) auto-injector for children with active lupus nephritis
24 June 2025 - With this approval, paediatric patients aged five years and older with active lupus nephritis will have ...