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RSS FeedPosted by Michael Wonder on 13 Jul 2025
Bayer files for EU approval of gadoquatrane
10 July 2025 - Submission of marketing authorization application to the EMA seeking approval for investigational low dose gadoquatrane for contrast-enhanced ...
Posted by Michael Wonder on 13 Jul 2025
Milestone Pharmaceuticals announces FDA acceptance of the company’s response to the CRL for Cardamyst (etripamil) nasal spray
11 July 2025 - New PDUFA action date of 13 December 2025. ...
Posted by Michael Wonder on 13 Jul 2025
Ultragenyx receives complete response letter from FDA for UX111 AAV gene therapy to treat Sanfilippo syndrome type A
11 July 2025 - complete response letter cited specific chemistry, manufacturing and controls related observations that are resolvable. ...
Posted by Michael Wonder on 11 Jul 2025
Capricor Therapeutics provides regulatory update on deramiocel BLA for Duchenne muscular systrophy
11 July 2025 - Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in ...
Posted by Michael Wonder on 09 Jul 2025
New Wegovy dose submitted to EMA for approval, with 1 in 3 trial participants achieving 25% or more weight loss
8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...
Posted by Michael Wonder on 09 Jul 2025
Supplemental new drug application submitted to US FDA for Caplyta (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
8 July 2025 - Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in ...
Posted by Michael Wonder on 08 Jul 2025
Denali Therapeutics announces FDA acceptance and priority review of biologics license application for tividenofusp alfa for Hunter syndrome
7 July 2025 - FDA assigns PDUFA target action date of 5 January 2026, for decision on accelerated approval. ...
Posted by Michael Wonder on 04 Jul 2025
Johnson & Johnson submits application to the EMA seeking indication extension of Akeega (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations
3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with ...
Posted by Michael Wonder on 01 Jul 2025
Unicycive Therapeutics announces receipt of complete response letter for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
30 June 2025 - No other concerns stated, including pre-clinical, clinical, or safety data. ...
Posted by Michael Wonder on 28 Jun 2025
Omeros submits narsoplimab marketing authorization application to the EMA for the treatment of TA-TMA
27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...
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
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 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 ...