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RSS FeedPosted by Michael Wonder on 02 Mar 2026
FDA accepts Viatris supplemental new drug application for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia
25 February 2026 - Viatris today announced that the US FDA has accepted for review the supplemental new drug application ...
Posted by Michael Wonder on 01 Mar 2026
Eton Pharmaceuticals announces US FDA approval for Desmoda (desmopressin acetate) oral solution
25 February 2026 - Commercial launch expected on 9 March 2026. ...
Posted by Michael Wonder on 01 Mar 2026
US FDA approves BioMarin’s Palynziq (pegvaliase-pqpz) for adolescents 12 years of age and older with phenylketonuria
27 February 2026 - BioMarin today announced that the US FDA has approved the company's supplemental biologics license application for Palynziq ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves Novo Nordisk's Sogroya as the first and only once weekly, long-acting growth hormone for three additional paediatric indications
27 February 2026 - Novo Nordisk today announced that the US FDA has approved three new indications for once weekly Sogroya ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves once weekly Yuwivel (navepegritide) for children with achondroplasia aged 2 years and older
27 February 2026 - Rare paediatric disease priority review voucher granted in connection with approval. ...
Posted by Michael Wonder on 28 Feb 2026
Opus Genetics announces FDA acceptance of supplemental new drug application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia
25 February 2026 - Opus Genetics today announced that the US FDA has accepted for review the supplemental new drug ...
Posted 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 ...