Blog
RSS FeedPosted by Michael Wonder on 16 Jul 2025
Corcept submits new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
14 July 2025 - Corcept Therapeutics has submitted a new drug application to the US FDA for its proprietary, selective ...
Posted by Michael Wonder on 15 Jul 2025
US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk
14 July 2025 - FDA decision anticipated H1, 2026 ...
Posted by Michael Wonder on 15 Jul 2025
Atara Biotherapeutics provides regulatory and business updates on tabelecleucel
14 July 2025 - Atara Biotherapeutics resubmits tabelecleucel biologics license application for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease to ...
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
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 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 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 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
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 22 Jun 2025
Update on FDA review of ruxolitinib cream (Opzelura) for children ages 2-11 with atopic dermatitis
20 June 2025 - Incyte today announced that the US FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 19 Jun 2025
Bayer files for approval of gadoquatrane in the US
17 June 2025 - Bayer today announced the submission of a new drug application to the US FDA for its ...
Posted by Michael Wonder on 18 Jun 2025
FDA to issue new Commissioner’s national priority vouchers to companies supporting US national interests
17 June 2025 - The US FDA today announced its Commissioner’s National Priority Voucher program to enhance the health interests of ...