Blog
RSS FeedPosted by Michael Wonder on 08 Oct 2025
Vivace Therapeutics' VT3989 granted fast track designation by the US FDA for the treatment of mesothelioma
8 October 2025 - Vivace Therapeutics today announced that the US FDA has granted fast track designation to VT3989, the company's ...
Posted by Michael Wonder on 08 Oct 2025
FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma
8 October 2025 - Today, the FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous ...
Posted by Michael Wonder on 08 Oct 2025
US FDA approves Simponi (golimumab) for the treatment of paediatric ulcerative colitis
7 October 2025 - Johnson & Johnson today announced that the US FDA has approved Simponi (golimumab) for the treatment of ...
Posted by Michael Wonder on 07 Oct 2025
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...
Posted by Michael Wonder on 07 Oct 2025
FDA approves Arcutis’ Zoryve (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5
6 October 2025 - Commercial product expected to be available by the end of October 2025. ...
Posted by Michael Wonder on 07 Oct 2025
Spruce Biosciences receives US FDA breakthrough therapy designation for tralesinidase alfa enzyme replacement therapy in Sanfilippo syndrome type B
6 October 2025 - Breakthrough therapy designation supported by integrated long-term clinical data demonstrating normalisation in cerebral spinal fluid heparan sulphate ...
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 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 ...