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RSS FeedPosted by Michael Wonder on 10 Oct 2025
FDA approves expanded indication for Uzedy (risperidone) extended release injectable suspension as a treatment for adults living with bipolar I disorder
10 October 2025 - Teva Pharmaceuticals announced today that the US FDA has approved Uzedy (risperidone) as a once-monthly extended-release injectable ...
Posted by Michael Wonder on 10 Oct 2025
Cidara Therapeutics receives US FDA breakthrough therapy designation for CD388 in seasonal influenza prevention
9 October 2025 - Cidara Therapeutics today announced that the US FDA has granted breakthrough therapy designation for CD388 for prevention ...
Posted by Michael Wonder on 10 Oct 2025
Adcendo ApS announces FDA fast track designation granted to ADCE-D01 for the treatment of soft tissue sarcoma
9 October 2025 - Adcendo ApS today announced that the US FDA has granted fast track designation to ADCE-D01 for ...
Posted by Michael Wonder on 10 Oct 2025
Celltrion receives US FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept)
9 October 2025 - Celltrion today announced that the US FDA has approved Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept), for the ...
Posted by Michael Wonder on 10 Oct 2025
US FDA approves Boehringer’s Jascayd (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade
9 October 2025 - Approval is based on results from two clinical trials, which showed reduction in forced vital capacity decline ...
Posted by Michael Wonder on 09 Oct 2025
Richter and Hikma receive FDA approval for denosumab biosimilars Enoby and Xtrenbo, referencing Prolia and Xgeva
29 September 2025 - Gedeon Richter and Hikma Pharmaceuticals announce today that the US FDA has granted approval for the ...
Posted by Michael Wonder on 08 Oct 2025
Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval
8 October 2025 - Xspray Pharma has received a complete response letter from the US FDA concerning the Company’s new ...
Posted by Michael Wonder on 08 Oct 2025
Werewolf Therapeutics receives fast track designation from the US FDA for WTX-124, an investigational therapy for the treatment of cancer
8 October 2025 - Werewolf Therapeutics today announced that the Company has received fast track designation for the use of WTX-124 ...
Posted by Michael Wonder on 08 Oct 2025
Vivace Therapeutics' VT3989 granted fast track designation by the US FDA for the treatment of mesothelioma
8 October 2025 - Vivace Therapeutics today announced that the US FDA has granted fast track designation to VT3989, the company's ...
Posted by Michael Wonder on 08 Oct 2025
FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma
8 October 2025 - Today, the FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous ...
Posted by Michael Wonder on 08 Oct 2025
US FDA approves Simponi (golimumab) for the treatment of paediatric ulcerative colitis
7 October 2025 - Johnson & Johnson today announced that the US FDA has approved Simponi (golimumab) for the treatment of ...
Posted by Michael Wonder on 07 Oct 2025
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...
Posted by Michael Wonder on 07 Oct 2025
Orca Bio announces FDA acceptance and priority review of the biologics license application for Orca-T to treat haematological malignancies
6 October 2025 - FDA assigns PDUFA target action date of 6 April 2026. ...
Posted by Michael Wonder on 07 Oct 2025
FDA approves Arcutis’ Zoryve (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5
6 October 2025 - Commercial product expected to be available by the end of October 2025. ...
Posted by Michael Wonder on 07 Oct 2025
Spruce Biosciences receives US FDA breakthrough therapy designation for tralesinidase alfa enzyme replacement therapy in Sanfilippo syndrome type B
6 October 2025 - Breakthrough therapy designation supported by integrated long-term clinical data demonstrating normalisation in cerebral spinal fluid heparan sulphate ...