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RSS FeedPosted by Michael Wonder on 19 Aug 2025
Ultragenyx initiates rolling submission of niologics license application to US FDA for DTX401 AAV gene therapy for the Treatment of glycogen storage disease type Ia
18 August 2025 - Ultragenyx today announced the initiation of a rolling submission of a niologics license application to the US ...
Posted by Michael Wonder on 18 Aug 2025
RegenxBio announces FDA review extension of BLA for RGX-121 to treat patients with MPS II
18 August 2025 - RegenxBio today announced that the US FDA extended its review timeline of the biologics license application ...
Posted by Michael Wonder on 18 Aug 2025
Stealth BioTherapeutics resubmits new drug application for elamipretide for the treatment of Barth syndrome
18 August 2025 - Stealth BioTherapeutics today announced the resubmission of a new drug application to the US FDA for Barth ...
Posted by Michael Wonder on 17 Aug 2025
Wegovy approved in the US for the treatment of MASH
15 August 2025 - Novo Nordisk today announced that the US FDA has approved an additional indication for Wegovy (semaglutide ...
Posted by Michael Wonder on 16 Aug 2025
FDA approves first immunotherapy for recurrent respiratory papillomatosis
14 August 2025 - Today, the US FDA approved Papzimeos (zopapogene imadenovec-drba), a first of its kind non-replicating adenoviral vector-based immunotherapy ...
Posted by Michael Wonder on 12 Aug 2025
FDA approves Brinsupri (brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis, a serious, chronic lung disease
12 August 2025 - Brinsupri, a first in class DPP1 inhibitor targeting neutrophilic inflammation, is available by prescription through a comprehensive ...
Posted by Michael Wonder on 11 Aug 2025
Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea
11 August 2025 - 11 December assigned as PDUFA goal date for FDA decision ...
Posted by Michael Wonder on 11 Aug 2025
Lantheus announces FDA acceptance of NDA for new formulation for market leading PSMA PET imaging agent
6 August 2025 - PDUFA date set for March 6, 2026 ...
Posted by Michael Wonder on 08 Aug 2025
FDA approves expanded indication for Avtozma (tocilizumab-anoh) intravenous formulation in cytokine release syndrome
6 August 2025 - Approval of Avtozma (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and paediatric patients aged ...
Posted by Michael Wonder on 06 Aug 2025
FDA grants accelerated approval to dordaviprone for diffuse midline glioma
6 August 2025 -Today, the FDA granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and ...
Posted by Michael Wonder on 04 Aug 2025
Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by US FDA in fifth cancer type for relapsed or refractory marginal zone lymphoma
4 August 2025 - Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application ...
Posted by Michael Wonder on 02 Aug 2025
Update on US regulatory review of supplemental biologics license application
1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex ...
Posted by Michael Wonder on 01 Aug 2025
Lenz Therapeutics announces US FDA approval of Vizz for the treatment of presbyopia
31 July 2025 - Vizz samples and product availability in the US expected as early as October 2025. ...
Posted by Michael Wonder on 01 Aug 2025
Novartis twice yearly Leqvio (inclisiran) receives FDA approval for new indication enabling first-line use
31 July 2025 - 4 out of 5 atherosclerotic cardiovascular disease patients do not reach guideline-recommended LDL-C target, reinforcing urgent need ...
Posted by Michael Wonder on 30 Jul 2025
Johnson & Johnson files with US FDA to include new evidence in Tremfya (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis
29 July 2025 - Submission is supported by 24 week results from the Phase 3b APEX study in adults with active ...