Blog
RSS FeedPosted 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
BridgeBio selects PANTHERx Rare specialty pharmacy for distribution of Attruby (acoramidis)
26 November 2024 - PANTHERx Rare is pleased to announce that it was selected by BridgeBio for the distribution of Attruby ...
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
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
Health Canada authorises Carvykti (ciltacabtagene autoleucel) for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
21 November 2024 - Authorisation is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with ...
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 30 Nov 2024
Nurix Therapeutics receives PRIME designation from the EMA for NX-5948 for the treatment of relapsed or refractory chronic lymphocytic leukaemia
20 November 2024 - Pivotal trials of NX-5948 are planned to initiate in 2025. ...
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 28 Nov 2024
European Commission approves Pfizer’s Hympavzi (marstacimab) for the treatment of adults and adolescents with severe haemophilia A or B without inhibitors
20 November 2024 - In the EU, Hympavzi is the first once weekly subcutaneous treatment approved for eligible people living with ...
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. ...