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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
Ifinatamab deruxtecan granted breakthrough therapy designation by US FDA for patients with pre-treated extensive stage small cell lung cancer
18 August 2025 - First breakthrough therapy designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based on IDeate-Lung01 phase 2 ...
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 16 Aug 2025
Tonix Pharmaceuticals announces FDA approval of Tonmya (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia
15 August 2025 - Commercial availability of Tonmya is expected in the fourth quarter. ...
Posted by Michael Wonder on 16 Aug 2025
Halda Therapeutics receives FDA fast track designation for HLD-0915 for the treatment of metastatic castration-resistant prostate cancer
14 August 2025 - Halda Therapeutics today announced that the US FDA granted fast track designation to HLD-0915, the company’s ...
Posted by Michael Wonder on 15 Aug 2025
Thermo Fisher receives FDA approval for NGS based companion diagnostic for new non-small cell lung cancer treatment
11 August 2025 - Thermo Fisher Scientific has received approval from the US FDA for its Oncomine Dx Target Test as ...
Posted by Michael Wonder on 13 Aug 2025
Creative Medical Technology secures FDA fast track designation for CELZ-201-DDT - advancing breakthrough therapy for chronic lower back pain
13 August 2025 - Creative Medical Technology Holdings today announced that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 13 Aug 2025
AAVantgarde Bio announces FDA fast track designation for AAVB-039 for the treatment of Stargardt disease
12 August 2025 - AAVantgarde Bio today announced that the US FDA has granted fast track designation for AAVB-039, the company’s ...
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 12 Aug 2025
NRx Pharmaceuticals granted FDA fast track designation for NRX-100 for suicidal ideation in patients with depression, including bipolar depression
11 August 2025 - NRx Pharmaceuticals today announced US FDA has granted fast track designation to NRX-100 for the treatment of ...
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 ...