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RSS FeedPosted by Michael Wonder on 28 Jan 2025
Saol Therapeutics announces FDA acceptance of new drug application for SL1009 for treatment of pyruvate dehydrogenase complex deficiency
28 January 2025 - Saol Therapeutics announced today that the US FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 28 Jan 2025
Vanda Pharmaceuticals accepts FDA opportunity for a hearing on new drug application for tradipitant in gastroparesis
27 January 2025 - Highlights faulty FDA review. ...
Posted by Michael Wonder on 28 Jan 2025
Enhertu approved in the US as first HER2 directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies
27 January 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 27 Jan 2025
FDA grants priority review to Merck’s application for Welireg (belzutifan) for the treatment of patients with advanced pheochromocytoma and paraganglioma
27 January 2025 - Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain ...
Posted 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 ...