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RSS FeedPosted by Michael Wonder on 30 Apr 2025
Johnson & Johnson receives FDA approval for Imaavy (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis
30 April 2025 - First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and paediatric generalised myasthenia gravis. ...
Posted by Michael Wonder on 30 Apr 2025
US FDA approves Zevaskyn (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa
29 April 2025 - Rare paediatric disease priority review voucher granted by FDA. ...
Posted by Michael Wonder on 30 Apr 2025
Roche granted FDA breakthrough device designation for first AI-driven companion diagnostic for non-small cell lung cancer
29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to ...
Posted by Michael Wonder on 29 Apr 2025
BioInvent receives FDA fast track designation for BI-1808 for the treatment of cutaneous T-cell lymphoma
29 April 2025 - BioInvent today announces that the US FDA has granted fast track designation to BI-1808, a first-in-class ...
Posted by Michael Wonder on 29 Apr 2025
Incyclix Bio granted US FDA fast track designation for INX-315 to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer
29 April 2025 - Incyclix Bio today announced that the US FDA has granted fast track designation for INX-315 for ...
Posted by Michael Wonder on 29 Apr 2025
Innorna announces FDA rare paediatric disease designation granted to IN013 for treatment of Wilson disease
25 February 2025 - Innorna is thrilled to announce that the US FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 29 Apr 2025
Rinvoq (upadacitinib) receives US FDA approval for giant cell arteritis
29 April 2025 - Rinvoq (upadacitinib) is now the first and only oral Janus kinase inhibitor approved for the treatment of ...
Posted by Michael Wonder on 29 Apr 2025
Eton Pharmaceuticals announces submission of NDA for ET-600 (desmopressin oral solution)
28 April 2025 - Expected 10 month review; commercial preparations underway for a potential Q1 2026 launch. ...
Posted by Michael Wonder on 28 Apr 2025
Telix provides regulatory update on TLX101-CDx
28 April 2028 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...
Posted by Michael Wonder on 27 Apr 2025
AbbVie submits biologics license application to US FDA for trenibotulinumtoxinE (TrenibotE) for the treatment of glabellar lines
24 April 2025 - Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program. ...
Posted by Michael Wonder on 25 Apr 2025
FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma
23 April 2025 - Today, the FDA approved penpulimab-kcqx (Akeso Biopharma) with cisplatin or carboplatin and gemcitabine for the first-line ...
Posted by Michael Wonder on 24 Apr 2025
Latest update on US FDA BLA for Novavax's COVID-19 vaccine
23 April 2025 - We believe that our biologics license application is approvable based on conversations with the US FDA, ...
Posted by Michael Wonder on 22 Apr 2025
FDA grants breakthrough therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
22 April 2025 - Breakthrough therapy designation is based on the encouraging survival data from the Phase 1 BrainChild-03 trial in ...
Posted by Michael Wonder on 18 Apr 2025
Regeneron provides update on Eylea HD (aflibercept) injection 8 mg supplemental biologics license application
18 April 2025 - Regeneron Pharmaceuticalstoday announced that the US FDA has issued a complete response letter regarding the supplemental biologics ...
Posted by Michael Wonder on 18 Apr 2025
Dupixent (dupilumab) approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria
18 April 2025 - Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo. ...