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RSS FeedPosted 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 18 Nov 2024
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for adult patients with unresectable non-epithelioid malignant pleural mesothelioma
15 November 2024 - Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial. ...
Posted by Michael Wonder on 18 Nov 2024
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR mutated lung cancer
18 November 2024 - Recommendation based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...
Posted by Michael Wonder on 18 Nov 2024
AbbVie receives European Commission approval of Elahere (mirvetuximab soravtansine) for the treatment of platinum resistant ovarian cancer
18 November 2024 - VENTANA FOLR RxDx assay, the companion diagnostic to identify ovarian cancer patients eligible for Elahere, also ...
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 16 Nov 2024
AlveoGene receives rare paediatric disease designation from FDA for AVG-002, its novel, inhaled gene therapy for lethal neonatal surfactant protein B deficiency
15 November 2024 - AlveoGene announces that it has been granted a rare paediatric disease designation by the US FDA ...
Posted by Michael Wonder on 16 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for repotrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer and advanced NTRK positive solid tumours
15 November 2024 - Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity ...
Posted by Michael Wonder on 15 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
15 October 2024 - Opinion based on results from the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...
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 ...