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RSS FeedPosted by Michael Wonder on 29 Oct 2024
FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukaemia
29 October 2024 - Today, the FDA granted accelerated approval to asciminib (Scemblix, Novartis) for adult patients with newly diagnosed ...
Posted by Michael Wonder on 28 Oct 2024
Astellas provides update on marketing authorisation application for avacincaptad pegol in the European Union
28 October 2024 - Astellas today announced the company's decision to withdraw its marketing authorisation application from the EMA for ...
Posted by Michael Wonder on 28 Oct 2024
Fasenra approved in the EU for eosinophilic granulomatosis with polyangiitis
28 October 2024 - New indication supported by the MANDARA trial, which showed nearly 60% of patients achieved remission and ...
Posted by Michael Wonder on 26 Oct 2024
FDA grants rare paediatric disease designation to Omeros’ MASP-3 inhibitor zaltenibart for treatment of C3 glomerulopathy
24 October 2024 - Phase 3 studies on the horizon in both PNH and C3G. ...
Posted by Michael Wonder on 26 Oct 2024
Iterum Therapeutics receives US FDA approval of Orlynvah (oral sulopenem) for the treatment of uncomplicated urinary tract infections
25 October 2024 - Orlynvah is the first oral penem approved for use in the US and the second FDA approved ...
Posted by Michael Wonder on 26 Oct 2024
Lenz Therapeutics announces FDA acceptance of new drug application for LNZ100 for the treatment of presbyopia
21 October 2024 - FDA sets PDUFA target date of 8 August 2025. ...
Posted by Michael Wonder on 25 Oct 2024
Shionogi receives US FDA fast track designation for the novel anti-respiratory syncytial virus drug candidate S-337395
24 October 2024 - Shionogi announced that the US FDA has granted fast track designation for S-337395, our novel anti-respiratory syncytial ...
Posted by Michael Wonder on 24 Oct 2024
Merck’s Keytruda (pembrolizumab) receives 30th approval from European Commission with two new indications in gynaecologic cancers
24 October 2024 - Keytruda plus chemotherapy is the first approval in the EU for an anti-PD-1 therapy combined with chemotherapy ...
Posted by Michael Wonder on 24 Oct 2024
HiberCell receives FDA fast track designation for HC-7366 for the treatment of relapsed or refractory acute myeloid leukaemia
23 October 2024 - HiberCell is pleased to announce that the US FDA has granted fast track designation to HC-7366 for ...
Posted by Michael Wonder on 23 Oct 2024
FDA accepts new drug application and grants priority review for TLX101-CDx (Pixclara) brain cancer imaging agent
24 October 2024 - Telix Pharmaceuticals today announces that the US FDA has accepted the new drug application for TLX101-CDx (Pixclara), ...
Posted by Michael Wonder on 23 Oct 2024
FDA approves NGS based companion diagnostic for first targeted therapy for patients with grade 2 IDH mutant glioma
21 October 2024 - Oncomine Dx target test to identify patients eligible for Servier’s Voranigo (vorasidenib) tablet, the only FDA ...
Posted by Michael Wonder on 23 Oct 2024
US FDA approves Pfizer’s RSV vaccine Abrysvo for adults aged 18 to 59 at increased risk for disease
22 October 2024 - Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower ...
Posted by Michael Wonder on 23 Oct 2024
Health Canada approves first and only oral targeted treatment for brain cancer
22 October 2024 - Pivotal Phase 3 study shows significant improvement in progression-free survival with a favourable safety profile. ...
Posted by Michael Wonder on 23 Oct 2024
Cothera Bioscience announces FDA fast track designation for clinical program PC-002
14 October 2024 - Cothera Bioscience is pleased to announce that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 22 Oct 2024
Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly
22 October 2024 - The FDA issues a complete response letter for CAM2029 pending FDA’s assessment of responses from a third ...