Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 01 Dec 2024
Attruby (acoramidis), a near complete TTR stabiliser (≥90%), approved by FDA to reduce cardiovascular death and cardiovascular related hospitalisation in ATTR-CM patients
22 November 2024 - Attruby is the first and only approved product with a label specifying near complete stabilisation of TTR. ...
Posted by Michael Wonder on 30 Nov 2024
FDA approves updated drug labelling for fludarabine phosphate under Project Renewal
19 November 2024 - Today, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project ...
Posted by Michael Wonder on 28 Nov 2024
US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Tepmetko (tepotinib) to identify patients with MET exon 14 skipping alterations in non-small cell lung cancer
18 November 2024 - FoundationOne Liquid CDx is the first FDA approved companion diagnostic to identify patients who may be ...
Posted by Michael Wonder on 27 Nov 2024
UCB receives US FDA approval for Bimzelx (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa
20 November 2024 - Approval is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD ...
Posted by Michael Wonder on 27 Nov 2024
Astellas provides update on Izervay (avacincaptad pegol intravitreal solution) supplemental new drug application
19 November 2024 - Astellas today announced the US FDA issued a complete response letter on 15 November 2024, regarding the ...
Posted by Michael Wonder on 17 Nov 2024
Azurity Pharmaceuticals announces FDA approval of Danziten (nilotinib) tablets, the first and only nilotinib with no mealtime restrictions
14 November 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Danziten, the first and only nilotinib with ...
Posted by Michael Wonder on 15 Nov 2024
FDA approves revumenib for relapsed or refractory acute leukaemia with a KMT2A translocation
15 November 2024 - Today, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals), a menin inhibitor, for relapsed or refractory acute ...