Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 18 Jun 2025
Obecabtagene autoleucel for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukaemia
13 June 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 18 Jun 2025
Duke Street Bio receives FDA fast track designation for DSB2455
10 June 2025 - Duke Street Bio today announced that the US FDA has granted fast track designation to DSB2455, its ...
Posted by Michael Wonder on 18 Jun 2025
PHARMAC declines inactive medicine applications
18 June 2025 - PHARMAC has declined 48 inactive funding applications so that it is clearer what medicines are currently ...
Posted by Michael Wonder on 18 Jun 2025
Dyne Therapeutics announces FDA breakthrough therapy designation for DYNE-101
17 June 2025 - - Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-101 for ...
Posted by Michael Wonder on 18 Jun 2025
BioAegis Therapeutics receives FDA fast track designation for lead product, recombinant human gelsolin, for the treatment of acute respiratory distress syndrome
17 June 2025 - BioAegis Therapeutics announces that the US FDA has granted fast track designation to its lead product candidate, ...
Posted by Michael Wonder on 18 Jun 2025
Johnson & Johnson seeks US FDA approval of Stelara (ustekinumab) for the treatment of paediatric Crohn’s disease
17 June 2025 - Supported by 52 week data from the Phase 3 UNITI-Jr study, submission aims to expand Stelara indication ...
Posted by Michael Wonder on 17 Jun 2025
Tisento Therapeutics receives US FDA fast track designation for zagociguat for the treatment of MELA
17 June 2025 - Global Phase 2b PRIZM study of zagociguat is currently enrolling participants with MELAS. ...
Posted by Michael Wonder on 17 Jun 2025
Ferrer receives FDA fast track designation for FNP-223 in progressive supranuclear palsy
17 June 2025 - Ferrer has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development ...
Posted by Michael Wonder on 17 Jun 2025
Milestone Pharmaceuticals submits response to the FDA’s CRL for Cardamyst (etripamil) nasal spray for PSVT following type A meeting
16 June 2025 - Milestone Pharmaceuticals today announced submission of its response to the US FDA’s complete response letter regarding its ...
Posted by Michael Wonder on 17 Jun 2025
US FDA approves CSL's Andembry (garadacimab-gxii), the only prophylactic hereditary angioedema treatment targeting factor XIIa with once monthly dosing for all patients from the start
16 June 2025 - Once monthly dosing reduced HAE attacks by a median of more than 99% and a least squares ...
Posted by Michael Wonder on 17 Jun 2025
Vanflyta is now approved in Canada specifically for adult patients with newly diagnosed FLT3-ITD positive AML
16 June 2025 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival ...
Posted by Michael Wonder on 17 Jun 2025
Averoa receives European marketing authorisation for Xoanacyl, an oral therapy for chronic kidney disease
16 June 2025 - AVEROA actively seeking strategic partners and investors to bring Xoanacyl to European patients and unlock full ...
Posted by Michael Wonder on 16 Jun 2025
New Chief Executive for PHARMAC
17 June 2025 - PHARMAC’s Board has appointed a new Chief Executive to lead the organisation. ...
Posted by Michael Wonder on 16 Jun 2025
SolasCure receives FDA fast track designation for Aurase wound gel to treat calciphylaxis ulcers
16 June 2025 - Solascure today announced that the US FDA has granted fast track designation for its investigational Aurase wound ...
Posted by Michael Wonder on 16 Jun 2025
Aquestive Therapeutics announces FDA acceptance of new drug application and PDUFA date for Anaphylm for the treatment of severe allergic reactions
16 June 2025 - FDA assigns PDUFA target action date of 31 January 2026 ...