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RSS FeedPosted by Michael Wonder on 29 Apr 2024
FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
29 April 2024 - Today, the FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen) for recurrent or metastatic cervical ...
Posted by Michael Wonder on 29 Apr 2024
Celltrion USA signs agreement with Express Scripts for its therapy for autoimmune diseases including the first FDA approved subcutaneous infliximab Zymfentra
28 April 2024 - Celltrion USA announced today that it has signed an agreement with Express Scripts, one of the nation's ...
Posted by Michael Wonder on 27 Apr 2024
A milestone in facilitating the development of safe and effective biosimilars
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...
Posted by Michael Wonder on 26 Apr 2024
FDA grants Medivir´s MIV-711 rare paediatric disease designation and orphan drug designation for the treatment of Legg-Calvé-Perthes Disease
25 April 2024 - Medivir announced today that its selective cathepsin K inhibitor, MIV-711, has been granted rare paediatric disease designation ...
Posted by Michael Wonder on 25 Apr 2024
Compass Therapeutics receives FDA fast track designation for the investigation of CTX-009 in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract tumours that have been previously treated
25 April 2024 - Compass Therapeutics today announced that the US FDA has granted fast track designation to CTX-009, the Company’s ...
Posted by Michael Wonder on 25 Apr 2024
US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer
24 April 2024 - 23 August 2024 assigned as Prescription Drug User Fee Act action date for FDA decision. ...
Posted by Michael Wonder on 25 Apr 2024
Deverra Therapeutics granted FDA fast track designation for DVX101 (dilanubicel) for the treatment of acute myeloid leukaemia
24 April 2024 - Deverra Therapeutics today announced that the US FDA granted fast track designation to dilanubicel, the Company's ...
Posted by Michael Wonder on 25 Apr 2024
Bashing accelerated approval isn’t supported by the data
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
Posted by Michael Wonder on 25 Apr 2024
FDA approves new treatment for uncomplicated urinary tract infections
24 April 2024 - Today, the US FDA approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary ...
Posted by Michael Wonder on 23 Apr 2024
FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF altered paediatric low-grade glioma
23 April 2024 - Today, the FDA granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals) for patients 6 months ...
Posted by Michael Wonder on 23 Apr 2024
Medicure receives US FDA fast track designation for MC-1 for PNPO deficiency
23 April 2024 - Medicure announced today that through its subsidiary, Medicure International, the US FDA has granted fast track designation ...
Posted by Michael Wonder on 23 Apr 2024
FDA approves lutetium Lu 177 dotatate for paediatric patients 12 years and older with GEP-NETs
23 April 2024 - Today, the FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) for paediatric patients 12 ...
Posted by Michael Wonder on 23 Apr 2024
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...
Posted by Michael Wonder on 23 Apr 2024
Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments
22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...
Posted by Michael Wonder on 22 Apr 2024
Kura Oncology receives breakthrough therapy designation for ziftomenib in NPM1 mutant AML
22 April 2024 - Ziftomenib is the first investigational treatment to be granted breakthrough therapy designation for NPM1 mutant AML. ...