Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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 ...
Posted by Michael Wonder on 16 Jun 2025
KalVista Pharmaceuticals announces FDA will not meet PDUFA goal date for sebetralstat NDA for hereditary angioedema due to FDA resource constraints
13 June 2025 - Agency indicates anticipated decision within four weeks ...
Posted by Michael Wonder on 16 Jun 2025
EMA publishes agenda for 16-19 June 2025 CHMP meeting
16 June 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 16 Jun 2025
Celltrion announces US FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients
15 June 2025 - Approval of 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for ...
Posted by Michael Wonder on 14 Jun 2025
No drug price pledges by Pfizer, others in talks with US Government, Pfizer CEO says
9 June 2025 - Pfizer and other drug companies have met with the Trump administration to discuss lowering US drug ...
Posted by Michael Wonder on 14 Jun 2025
Xediton Pharmaceuticals announced today the Canadian approval and availability of Vabomere (meropenem-vaborbactam) in Canada
12 June 2025 - Xediton Pharmaceuticals is proud to announce that Vabomere (meropenem-vaborbactam) has been approved by Health Canada and ...
Posted by Michael Wonder on 14 Jun 2025
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA to expand use in adults 18 years and older
13 June 2025 - Regulatory decision anticipated H1, 2026. ...