Blog
RSS FeedPosted by Michael Wonder on 30 Nov 2024
Johnson & Johnson seeks US FDA approval for subcutaneous induction regimen of Tremfya (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor
22 November 2024 - Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission ...
Posted by Michael Wonder on 30 Nov 2024
US FDA accepts supplemental new drug application for Nubeqa (darolutamide) for the treatment of patients with metastatic hormone sensitive prostate cancer
21 November 2024 - Submission based on positive results from the Phase 3 ARANOTE trial which showed Nubeqa (darolutamide) plus androgen ...
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 29 Nov 2024
FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2 positive biliary tract cancer
20 November 2024 - Today, the FDA granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals), a bispecific HER2 directed antibody, ...
Posted by Michael Wonder on 29 Nov 2024
Replimune receives breakthrough therapy designation for RP1 and submits RP1 biologics license application to the FDA under the accelerated approval pathway
21 November 2024 - Replimune today announced that it has submitted a biologics license application to the FDA for RP1 (vusolimogene ...
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 21 Nov 2024
Arrowhead Pharmaceuticals submits new drug application to US FDA for plozasiran for the treatment of familial chylomicronemia syndrome
18 November 2024 - The new drug application is based on positive results from the Phase 3 PALISADE study. ...
Posted by Michael Wonder on 21 Nov 2024
ImmuneSensor Therapeutics receives orphan drug and rare paediatric disease designations from the US FDA for cGAS inhibitor drug candidate, IMSB301, for the treatment of Aicardi Goutières syndrome
20 November 2024 - ImmuneSensor Therapeutics announced that the US FDA has granted both orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 19 Nov 2024
FDA grants breakthrough therapy designation to Huahui Health's libevitug (HH-003) for treatment of chronic hepatitis D virus infection
18 November 2024 - Huahui Health today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an ...
Posted by Michael Wonder on 19 Nov 2024
Alkeus Pharmaceuticals receives FDA rare paediatric disease and fast track designations for gildeuretinol as a treatment for Stargardt disease
18 November 2024 - Alkeus Pharmaceuticals today announced that gildeuretinol (ALK-001), an investigational oral therapy, has received rare paediatric disease and ...
Posted by Michael Wonder on 18 Nov 2024
Vaderis receives FDA fast track designation for VAD044 for the treatment of hereditary haemorrhagic telangiectasia
18 November 2024 - Vaderis Therapeutics today announces that the US FDA has designated the allosteric AKT inhibitor VAD044 a fast ...
Posted by Michael Wonder on 18 Nov 2024
Alentis receives FDA fast track designation for ALE.P02 for the treatment of CLDN1 positive squamous solid tumours
18 November 2024 - ALE.P02 is a first in class antibody-drug conjugate targeting CLDN1. ...
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 ...