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RSS FeedPosted by Michael Wonder on 18 Jun 2025
Duke Street Bio receives FDA fast track designation for DSB2455
10 June 2025 - Duke Street Bio today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
Posted by Michael Wonder on 18 Jun 2025
Dyne Therapeutics announces FDA breakthrough therapy designation for DYNE-101
17 June 2025 - - Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-101 for ...
Posted by Michael Wonder on 18 Jun 2025
BioAegis Therapeutics receives FDA fast track designation for lead product, recombinant human gelsolin, for the treatment of acute respiratory distress syndrome
17 June 2025 - BioAegis Therapeutics announces that the US FDA has granted fast track designation to its lead product candidate, ...
Posted by Michael Wonder on 18 Jun 2025
Johnson & Johnson seeks US FDA approval of Stelara (ustekinumab) for the treatment of paediatric Crohn’s disease
17 June 2025 - Supported by 52 week data from the Phase 3 UNITI-Jr study, submission aims to expand Stelara indication ...
Posted by Michael Wonder on 17 Jun 2025
Tisento Therapeutics receives US FDA fast track designation for zagociguat for the treatment of MELA
17 June 2025 - Global Phase 2b PRIZM study of zagociguat is currently enrolling participants with MELAS. ...
Posted by Michael Wonder on 17 Jun 2025
Ferrer receives FDA fast track designation for FNP-223 in progressive supranuclear palsy
17 June 2025 - Ferrer has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development ...
Posted by Michael Wonder on 17 Jun 2025
Milestone Pharmaceuticals submits response to the FDA’s CRL for Cardamyst (etripamil) nasal spray for PSVT following type A meeting
16 June 2025 - Milestone Pharmaceuticals today announced submission of its response to the US FDA’s complete response letter regarding its ...
Posted by Michael Wonder on 17 Jun 2025
US FDA approves CSL's Andembry (garadacimab-gxii), the only prophylactic hereditary angioedema treatment targeting factor XIIa with once monthly dosing for all patients from the start
16 June 2025 - Once monthly dosing reduced HAE attacks by a median of more than 99& and a least squares ...
Posted by Michael Wonder on 16 Jun 2025
SolasCure receives FDA fast track designation for Aurase wound gel to treat calciphylaxis ulcers
16 June 2025 - Solascure today announced that the US FDA has granted fast track designation for its investigational Aurase wound ...
Posted by Michael Wonder on 16 Jun 2025
Aquestive Therapeutics announces FDA acceptance of new drug application and PDUFA date for Anaphylm for the treatment of severe allergic reactions
16 June 2025 - FDA assigns PDUFA target action date of 31 January 2026 ...
Posted by Michael Wonder on 16 Jun 2025
KalVista Pharmaceuticals announces FDA will not meet PDUFA goal date for sebetralstat NDA for hereditary angioedema due to FDA resource constraints
13 June 2025 - Agency indicates anticipated decision within four weeks ...
Posted by Michael Wonder on 16 Jun 2025
Celltrion announces US FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients
15 June 2025 - Approval of 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for ...
Posted by Michael Wonder on 14 Jun 2025
Moderna receives US FDA approval for RSV vaccine, mRESVIA, in adults aged 18–59 at increased risk for RSV disease
12 June 2025 - Expanded indication builds on existing US FDA approval of mRESVIA for adults aged 60 and older. ...
Posted by Michael Wonder on 13 Jun 2025
FDA grants priority review for zoliflodacin new drug application for the treatment of uncomplicated gonorrhoea
12 June 2025 - Innoviva Specialty Therapeutics today announced that the US FDA has granted priority review for the new drug ...
Posted by Michael Wonder on 12 Jun 2025
Sumitomo Pharma America announces that nuvisertib (TP-3654) has received FDA fast track designation for the treatment of myelofibrosis
12 June 2025 - Nuvisertib (TP-3654), an investigational highly selective oral PIM1 kinase inhibitor, is being evaluated in patients with ...