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RSS FeedPosted 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 19 Jan 2025
Long wait for cancer drug approvals causing 'great anguish' among patients, doctors
18 January 2025 - Potentially life-saving treatments delayed by bureaucracy, doctors say. ...
Posted by Michael Wonder on 16 Jan 2025
Foresee Pharmaceuticals announces the PDUFA goal date for the 3 month version of Camcevi is 29 August 2025
13 January 2025 - Foresee Pharmaceuticals announces that the US FDA issued a Day 74 letter. ...
Posted by Michael Wonder on 24 Dec 2024
Tonix Pharmaceuticals announces PDUFA goal date of 15 August 2025 for FDA decision on US marketing approval for TNX-102 SL for fibromyalgia
23 December 2024 - New drug application based on two statistically significant Phase 3 studies of TNX-102 SL for the ...
Posted by Michael Wonder on 11 Dec 2024
Theratechnologies receives March 2025 PDUFA goal date for updated tesamorelin F8 formulation sBLA
10 December 2024 - Theratechnologies today announced that the US FDA has assigned a PDUFA goal date of 25 March ...
Posted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
Posted by Michael Wonder on 04 Dec 2024
Soleno Therapeutics announces FDA extension of review period for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
26 November 2024 - PDUFA target action date extended by three months to 27 March 2025. ...
Posted by Michael Wonder on 12 Nov 2024
Unicycive Therapeutics announces US FDA acceptance of the new drug application for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
11 November 2024 - FDA sets PDUFA action date of 28 June 2025. ...
Posted by Michael Wonder on 12 Nov 2024
Neurotech provides update on BLA for NT-501 as a treatment for macular telangiectasia type 2
8 November 2024 - Neurotech Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date by three months ...
Posted by Michael Wonder on 06 Nov 2024
Merus receives FDA extension of PDUFA for zenocutuzumab
5 November 2024 - Merus today announced that the US FDA has extended the PDUFA goal date for zenocutuzumab biologics ...
Posted by Michael Wonder on 05 Nov 2024
Update on FDA review of Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older
5 November 2024 - Organon today announced that the US FDA extended by three months the target action date of its ...
Posted by Michael Wonder on 20 Oct 2024
Intercept provides regulatory update regarding sNDA for Ocaliva
17 October 2024 - Intercept Pharmaceuticals today announced that the US FDA has informed the Company that it is continuing its ...
Posted by Michael Wonder on 03 Oct 2024
Improving efficiency of approval process for new medicines in the EU
2 October 2024 - EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and ...
Posted by Michael Wonder on 07 Sep 2024
KalVista announces FDA acceptance of new drug application for sebetralstat for oral on-demand treatment of hereditary angioedema
3 September 2024 - FDA PDUFA goal date of 17 June 2025. ...
Posted by Michael Wonder on 27 Aug 2024
Soleno Therapeutics announces US FDA acceptance for filing and priority review of NDA for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
27 August 2024 - Soleno Therapeutics today announced that the US FDA has accepted for filing its new drug application ...