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RSS FeedPosted 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 ...
Posted by Michael Wonder on 12 Jun 2025
FDA approves neo-adjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
12 June 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck ...
Posted by Michael Wonder on 12 Jun 2025
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
12 June 2025 - Today, the FDA approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade ...
Posted by Michael Wonder on 12 Jun 2025
US FDA approves tablet formulation of BeOne’s Brukinsa for all approved indications
11 June 2025 - New formulation provides patients with a simplified dosing experience—reducing pill burden and enhancing ease of administration—while ...
Posted by Michael Wonder on 12 Jun 2025
Radiopharm Theranostics granted US FDA fast track designation for RAD101 imaging in brain metastases
11 June 2025 - Radiopharm Theranostics today announced that the US FDA has granted fast track designation for RAD101 to ...
Posted by Michael Wonder on 11 Jun 2025
Cantargia’s nadunolimab antibody awarded US FDA fast track designation
11 June 2025 - Cantargia today announced that the US FDA has granted fast track designation to nadunolimab, Cantargia's anti-IL1RAP antibody ...
Posted by Michael Wonder on 11 Jun 2025
FDA approves taletrectinib for ROS1 positive non-small cell lung cancer
11 June 2025 - Today, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced ...
Posted by Michael Wonder on 11 Jun 2025
US FDA approves expanded indication for AbbVie's Mavyret (glecaprevir/pibrentasvir) as first and only treatment for people with acute hepatitis C virus
11 June 2025 - AbbVie today announced that the US FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral ...
Posted by Michael Wonder on 11 Jun 2025
Priorities for a new FDA
10 June 2025 - Why does it take more than 10 years for a new drug to come to market? Why ...