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RSS FeedPosted by Michael Wonder on 19 Dec 2024
FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in paediatric patients
18 December 2024 - Today, the FDA approved remestemcel-L-rknd (Ryoncil, Mesoblast), an allogeneic bone marrow derived mesenchymal stromal cell therapy, ...
Posted by Michael Wonder on 18 Dec 2024
FDA approves ensartinib for ALK positive locally advanced or metastatic non-small cell lung cancer
18 December 2024 - Today, the FDA approved ensartinib (Ensacove, Xcovery) for adult patients with anaplastic lymphoma kinase (ALK) positive ...
Posted by Michael Wonder on 18 Dec 2024
US FDA approves Celltrion's Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab)
17 December 2024 - Steqeyma is expected to be marketed in the US in February 2025. ...
Posted by Michael Wonder on 16 Dec 2024
FDA approves Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older
16 December 2024 - In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on Vtama cream ...
Posted by Michael Wonder on 14 Dec 2024
Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate to severe atopic dermatitis
13 December 2024 - Galderma today announced that the US FDA has approved Nemluvio (nemolizumab) for the treatment of patients 12 ...
Posted by Michael Wonder on 14 Dec 2024
FDA approves new treatment for congenital adrenal hyperplasia
13 December 2024 - Today, the US FDA approved Crenessity (crinecerfont) to be used together with glucocorticoids to control androgen levels ...
Posted by Michael Wonder on 13 Dec 2024
FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
13 December 2024 - Today, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, for ...
Posted by Michael Wonder on 11 Dec 2024
FDA approves Acetadote sNDA
9 December 2024 - New dosing regimen simplifies administration. ...
Posted by Michael Wonder on 07 Dec 2024
FDA approves durvalumab for limited-stage small cell lung cancer
4 December 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer whose ...
Posted by Michael Wonder on 07 Dec 2024
US FDA approves Biocon Biologics' Yesintek biosimilar to J&J's Stelara (ustekinumab)
2 December 2024 - Biocon Biologics announced today that the US FDA has approved Yesintek (ustekinumab-kfce), a biosimilar to the ...
Posted by Michael Wonder on 06 Dec 2024
US FDA approves StemCyte biologics license application for Regenecyte cord blood cell therapy product
22 November 2024 - StemCyte announced today that the US FDA has approved the Biologics License Application for its HPC, cord ...
Posted by Michael Wonder on 05 Dec 2024
Applied Therapeutics receives complete response letter from US FDA regarding new drug application for govorestat for classic galactosaemia
27 November 2024 - Applied Therapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 03 Dec 2024
Shorla Oncology announces FDA approval of Imkeldi (imatinib) oral solution, an oral liquid for the treatment of certain forms of leukaemia and other cancers
25 November 2024 - Imkeldi marks Shorla Oncology’s fourth FDA Approval. ...
Posted by Michael Wonder on 02 Dec 2024
US FDA approves AOP Health’s Rapiblyk (landiolol) for atrial fibrillation and atrial flutter in the critical care setting
27 November 2024 - AOP Orphan Pharmaceuticals announced that the US FDA has granted regulatory approval for Rapiblyk (landiolol) in the ...
Posted by Michael Wonder on 01 Dec 2024
Amneal resubmits DHE auto-injector new drug application and receives US FDA approval of exenatide, its first generic injectable GLP-1 agonist
21 November 2024 - Potential first and only DHE auto-injector for tough-to-treat migraines and cluster headaches. ...