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RSS FeedPosted by Michael Wonder on 07 Oct 2025
EG 427 receives US FDA fast track designation for EG110A DNA medicine in neurogenic bladder patients
6 October 2025 - EG 427 announced today that the US FDA granted fast track designation to EG110A, its novel DNA ...
Posted by Michael Wonder on 04 Oct 2025
Alzinova receives fast track designation from US FDA for ALZ-101 in Alzheimer’s disease
4 October 2025 - Alzinova today announces that the US FDA has granted fast track designation for the company’s vaccine candidate ...
Posted by Michael Wonder on 04 Oct 2025
Ensem Therapeutics announces ETX-636 granted fast track designation by the FDA for advanced breast cancer
1 October 2025 - Ensem Therapeutics today announced the US FDA granted fast track designation to its clinical stage pan mutant-specific ...
Posted by Michael Wonder on 04 Oct 2025
FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer
3 October 2025 - Regimen recommended in National Comprehensive Cancer Network Guidelines for small cell lung cancer. ...
Posted by Michael Wonder on 03 Oct 2025
Alto Neuroscience receives FDA fast track designation for ALTO-101 for the treatment of cognitive impairment associated with schizophrenia
3 October 2025 - Alto Neuroscience today announced that the US FDA has granted fast track designation to ALTO-101 for the ...
Posted by Michael Wonder on 03 Oct 2025
Nacuity Pharmaceuticals granted US FDA breakthrough therapy designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa
2 October 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to NPI-001 (N-acetylcysteine amide) ...
Posted by Michael Wonder on 03 Oct 2025
FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer
2 October 2025 - Today, the FDA approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq) or atezolizumab and ...
Posted by Michael Wonder on 03 Oct 2025
Taysha Gene Therapies announces FDA breakthrough therapy designation and provides positive regulatory update on TSHA-102 in Rett syndrome
2 October 2025 - Breakthrough therapy designation granted based on FDA’s review of available clinical evidence of safety and efficacy from ...
Posted by Michael Wonder on 02 Oct 2025
Calico Life Sciences announces US FDA fast track designation for investigational treatment of autosomal dominant polycystic kidney disease
2 October 2025 - Calico Life Sciences today announced the US FDA granted fast track designation for ABBV-CLS-628, an investigational therapy ...
Posted by Michael Wonder on 02 Oct 2025
Wockhardt submits new drug application to US FDA for zidebactam-cefepime (WCK 5222) for treatment of serious gram-negative infections
1 October 2025 - Wockhardt today announced the submission of new drug application to the US FDA for its novel ...
Posted by Michael Wonder on 02 Oct 2025
TAHO Pharma announces submission of new drug application to the US FDA for TAH3311 – the world’s first apixaban oral dissolving film – represents a transformational advancement in anti-coagulant therapy
30 September 2025 - TAHO Pharmaceuticals today announced the submission of its new drug application to the US FDA for TAH3311, ...
Posted by Michael Wonder on 02 Oct 2025
Pharming Group announces US FDA acceptance and priority review of supplemental new drug application for leniolisib in children with APDS aged 4 to 11 years
1 October 2025 - Pharming today announced that the US FDA has accepted its supplemental new drug application seeking approval for ...
Posted by Michael Wonder on 01 Oct 2025
Sentynl Therapeutics updates on its NDA for CUTX-101
1 October 2025 - Sentynl Therapeutics announced today that the US FDA has issued a complete response letter relating to ...
Posted by Michael Wonder on 01 Oct 2025
Bristol Myers Squibb’s anti-MTBR-tau targeting antibody, BMS-986446, granted fast track designation by US FDA for the treatment of Alzheimer’s disease
1 October 2025 - Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of ...
Posted by Michael Wonder on 01 Oct 2025
Enhertu followed by THP supplemental biologics license application accepted in the US for patients with high risk HER2 positive early stage breast cancer prior to surgery
1 October 2025 - Based on results from DESTINY-Breast11, the first Phase 3 trial to demonstrate benefit of Daiichi Sankyo ...