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RSS FeedPosted by Michael Wonder on 03 May 2025
FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
2 May 2025 - The FDA filing is based on the results of the Phase 3 OASIS 4 trial that evaluated ...
Posted by Michael Wonder on 02 May 2025
Satsuma Pharmaceuticals announces US FDA approval for Atzumi (dihydroergotamine) nasal powder for the acute treatment of migraine
30 April 2025 - Atzumi is the first and only product utilising the SMART (Simple MucoAdhesive Release Technology) platform which combines ...
Posted by Michael Wonder on 02 May 2025
Cytokinetics announces new PDUFA date for aficamten in obstructive hypertrophic cardiomyopathy
1 May 2025 - Cytokinetics today announced that the US FDA has extended the PDUFA action date for the New Drug ...
Posted by Michael Wonder on 01 May 2025
FDA grants OKYO Pharma fast track designation to urcosimod for neuropathic corneal pain
1 May 2025 - OKYO Pharma announces that the US FDA has granted fast track designation to urcosimod for the treatment ...
Posted by Michael Wonder on 30 Apr 2025
Q32 Bio announces FDA fast track designation granted to bempikibart (ADX-914) for the treatment of alopecia areata
30 April 2025 - Q32 Bio today announced that the US FDA has granted fast track designation to Q32 Bio's bempikibart ...
Posted 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. ...