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RSS FeedPosted by Michael Wonder on 27 Feb 2026
Xspray Pharma resubmits its FDA application for Dasynoc
26 February 2026 - Xspray Pharma has resubmitted its application for market approval for Dasynoc to the US FDA. ...
Posted by Michael Wonder on 27 Feb 2026
Neurogene announces FDA breakthrough therapy designation for NGN-401 gene therapy for Rett syndrome
26 February 2026 - Breakthrough therapy designation granted based on interim NGN-401 Phase 1/2 data demonstrating clinically meaningful, durable and multi-domain ...
Posted by Michael Wonder on 26 Feb 2026
Olezarsen sNDA accepted by the FDA for priority review for the treatment of severe hypertriglyceridaemia
26 February 2026 - Ionis Pharmaceuticals today announced that the US FDA has accepted for priority review the supplemental new ...
Posted by Michael Wonder on 26 Feb 2026
FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
26 February 2026 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 26 Feb 2026
Vanda Pharmaceuticals announces FDA acceptance of biologics license application filing for imsidolimab for the treatment of generalised pustular psoriasis
25 February 2026 - Vanda Pharmaceuticals today announced that the US FDA has accepted the filing of its biologics license application ...
Posted by Michael Wonder on 26 Feb 2026
FDA approves drug for adult and paediatric patients aged 6 and older with allergic fungal rhinosinusitis
25 February 2026 - The US FDA has approved Dupixent (dupilumab) for the treatment of adult and paediatric patients aged 6 ...
Posted by Michael Wonder on 25 Feb 2026
Siren Biotechnology receives FDA fast track designation for SRN-101 for the treatment of recurrent high grade glioma
24 February 2026 - Siren Biotechnology today announced that the US FDA has granted fast track designation to SRN-101, the ...
Posted by Michael Wonder on 25 Feb 2026
Aktis Oncology receives US FDA fast track designation for AKY-1189, a nectin-4 miniprotein radioconjugate
24 February 2026 - Aktis Oncology today announced that the US FDA has granted fast track designation to AKY-1189 for the ...
Posted by Michael Wonder on 25 Feb 2026
Larimar Therapeutics announces FDA breakthrough therapy designation for nomlabofusp in FA and reiterates planned BLA submission in June 2026
24 February 2026 - Larimar Therapeutics today announced the US FDA has granted breakthrough therapy designation to nomlabofusp, a frataxin protein ...
Posted by Michael Wonder on 25 Feb 2026
Johnson & Johnson seeks FDA approval of Imavvy (nipocalimab-aahu) as the first-ever FDA approved treatment for warm autoimmune hemolytic anemia
24 February 2026 - Data from the pivotal ENERGY trial showed Imavvy produced a rapid and durable hemoglobin response in wAIHA. ...
Posted by Michael Wonder on 24 Feb 2026
First treatment for vitiligo recommended by NICE for NHS use, bringing hope to over 80,000 people
24 February 2026 - For the first time, NICE has recommended a medicine that effectively treats the underlying cause of devastating ...
Posted by Michael Wonder on 24 Feb 2026
Novo Nordisk announces significant reduction in US list price for Wegovy, Ozempic and Rybelsus (semaglutide medicines), building on continued efforts to expand access
24 February 2026 - Today, Novo Nordisk announced that, effective 1 January 2027, the company will lower the list price, ...
Posted by Michael Wonder on 24 Feb 2026
US FDA has granted accelerated approval of Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in patients 2 years and older with arginase 1 deficiency
23 February 2026 - Immedica Pharma today announced that the US FDA has granted accelerated approval of Loargys (pegzilarginase-nbln), an ...
Posted by Michael Wonder on 24 Feb 2026
FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation
24 February 2026 - Today, the FDA granted traditional approval to encorafenib (Braftovi, Array BioPharma, a subsidiary of Pfizer) in ...
Posted by Michael Wonder on 24 Feb 2026
Dupixent (dupilumab) approved in the US as the first and only medicine for allergic fungal rhinosinusitis
24 February 2026 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) for the treatment ...