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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 01 Oct 2025
Disc Medicine announces submission of new drug application to US FDA for accelerated approval of bitopertin for patients with erythropoietic protoporphyria
30 September 2025 - Disc is seeking accelerated approval and priority review of its new drug application submission. ...
Posted by Michael Wonder on 01 Oct 2025
Novo Nordisk resubmits Awiqli to the FDA with potential to be the first once weekly basal insulin treatment for adults with type 2 diabetes
29 September 2025 - Awiqli (insulin icodec) injection, if approved, has the potential to be the first once weekly basal insulin ...
Posted by Michael Wonder on 30 Sep 2025
FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from methamphetamine
30 September 2025 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...
Posted by Michael Wonder on 30 Sep 2025
AbbVie submits biologics license application to US FDA for pivekimab sunirine - an investigational antibody-drug conjugate to treat rare cancer with limited treatment options
30 September 2025 - Biologics license application based on data from the global Phase 1/2 CADENZA trial. ...