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RSS FeedPosted by Michael Wonder on 27 Jan 2025
FDA approves Leqembi (lecanemab-irmb) IV maintenance dosing for the treatment of early Alzheimer's disease
26 January 2025 - Once every four weeks maintenance dosing may be easier for patients and care partners to continue ...
Posted by Michael Wonder on 24 Jan 2025
Clarity receives US FDA fast track designation for Cu 64 SAR-bisPSMA in biochemical recurrence of prostate cancer
24 January 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 23 Jan 2025
Stealth BioTherapeutics announces PDUFA action date extension for elamipretide to treat patients with Barth syndrome
23 January 2025 - New PDUFA action date of 29 April 2025, allows FDA additional time to complete review. ...
Posted by Michael Wonder on 23 Jan 2025
FDA and EMA accept applications for higher dose regimen of nusinersen in spinal muscular atrophy
23 January 2025 - Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher ...
Posted by Michael Wonder on 23 Jan 2025
Scilex announces that the US FDA has acknowledged the submission of our supplemental new drug application for Elyxyb in acute pain indication
22 January 2025 - Scilex today announced that the US FDA has acknowledged the submission of our supplemental new drug application ...
Posted by Michael Wonder on 23 Jan 2025
Medexus announces FDA approval of Grapafex (treosulphan) for injection
22 January 2025 - Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed ...
Posted by Michael Wonder on 22 Jan 2025
Replimune announces biologics license application acceptance and priority review for RP1 for the treatment of advanced melanoma
21 January 2025 - PDUFA action date of 22 July 2025, with priority review. ...
Posted by Michael Wonder on 22 Jan 2025
Bluejay Therapeutics receives US FDA breakthrough therapy designation for brelovitug (BJT-778) for the treatment of chronic hepatitis delta
21 January 2025 - Bluejay Therapeutics today announced that its lead product candidate brelovitug (also known as BJT-778) has received ...
Posted by Michael Wonder on 22 Jan 2025
Nacuity Pharmaceuticals granted US FDA fast track designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa
21 January 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted fast track designation to NPI-001 (N-acetylcysteine amide) ...
Posted by Michael Wonder on 21 Jan 2025
Dyne Therapeutics receives FDA fast track designation for DYNE-101 for the treatment of myotonic dystrophy type 1
21 January 2025 - Dyne Therapeutics today announced that the US FDA has granted fast track designation for DYNE-101 for ...
Posted by Michael Wonder on 21 Jan 2025
Solid Biosciences receives FDA fast track designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia
21 January 2025 - Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and ...
Posted by Michael Wonder on 21 Jan 2025
Life Molecular Imaging secures FDA fast track designation for [18F] florbetaben in diagnosing cardiac AL and ATTR amyloidosis
21 January 2025 - [18F] florbetaben has been granted a fast track designation for cardiac amyloidosis, which will expedite the development ...
Posted by Michael Wonder on 21 Jan 2025
Spravato (esketamine) approved in the US as the first and only monotherapy for adults with treatment-resistant depression
21 January 2024 - Following US FDA priority review, approval is based on data demonstrating Spravato alone met its primary endpoint ...
Posted by Michael Wonder on 19 Jan 2025
US FDA approves FoundationOne CDx as a companion diagnostic for Ojemda (tovorafenib) to treat the most common form of childhood brain tumour in paediatric patients
17 January 2025 - The approval supports the identification of therapeutic options for patients with relapsed or refractory BRAF altered paediatric ...
Posted by Michael Wonder on 18 Jan 2025
Arrowhead Pharmaceuticals announces acceptance of new drug application by US FDA of plozasiran for the treatment of familial chylomicronaemia syndrome
17 January 2025 - The new drug application is based on positive results from the Phase 3 PALISADE study. ...