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RSS FeedPosted by Michael Wonder on 31 Dec 2025
Cogent Biosciences announces submission of new drug application for bezuclastinib in non-advanced systemic mastocytosis
30 December 2025 - Cogent Biosciences today announced it has submitted its new drug application to the US FDA for ...
Posted by Michael Wonder on 31 Dec 2025
Ultragenyx completes rolling submission of biologics license application to US FDA for DTX401 AAV gene therapy for glycogen storage disease type Ia
30 December 2025 - If approved, DTX401 will be the first therapy approved to treat the underlying cause of glycogen storage ...
Posted by Michael Wonder on 31 Dec 2025
Vanda Pharmaceuticals announces FDA approval of Nereus (tradipitant) for the prevention of vomiting induced by motion: a historic scientific milestone in the prevention of motion sickness
30 December 2025 - Vanda Pharmaceuticals today announced that the US FDA has approved Nereus (tradipitant), an oral neurokinin-1 receptor antagonist, ...
Posted by Michael Wonder on 30 Dec 2025
FDA accepts for review Inovio's BLA for INO-3107 for the treatment of adults with recurrent respiratory papillomatosis
29 December 2025 - Inovio today announced that the US FDA accepted the company's biologics license application for INO-3107 for ...
Posted by Michael Wonder on 30 Dec 2025
Unicycive Therapeutics announces resubmission of new drug application for oxylanthanum carbonate
29 December 2025 - New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission. ...
Posted by Michael Wonder on 29 Dec 2025
US FDA approves Agios’ Aqvesme (mitapivat) for the treatment of anaemia in adults with alfa or beta-thalassaemia
23 December 2025 - Aqvesme expected to be available in late January 2026, following Aqvesme REMS program implementation. ...
Posted by Michael Wonder on 27 Dec 2025
Amneal announces FDA approval of denosumab biosimilars referencing Prolia and Xgeva
22 December 2025 - Company expects to commercialize six biosimilars across eight presentations by 2027. ...
Posted by Michael Wonder on 24 Dec 2025
FDA approves Omeros’ Yartemlea - first and only therapy indicated for transplant-associated thrombotic microangiopathy
24 December 2025 - Omeros Corporation today announced that the US FDA has approved Yartemlea (narsoplimab-wuug) for the treatment of haematopoietic ...
Posted by Michael Wonder on 24 Dec 2025
Organogenesis announces initiation of biologics license application for ReNu
23 December 2025 - Initial modules submitted to FDA under rolling review; final modules expected in the first half of ...
Posted by Michael Wonder on 24 Dec 2025
Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis
24 December 2025 - The US FDA has issued a complete response letter for the new drug application of tolebrutinib ...
Posted by Michael Wonder on 23 Dec 2025
Viridian Therapeutics announces BLA acceptance and priority review for veligrotug for the treatment of thyroid eye disease
22 December 2025 - PDUFA target action date of 30 June 2026. ...
Posted by Michael Wonder on 23 Dec 2025
FDA approves Novo Nordisk's Wegovy pill, the first and only oral GLP-1 for weight loss in adults
22 December 2025 - 1.5 mg starting dose available in early January for $149/month with savings offers; Wegovy pill is being ...
Posted by Michael Wonder on 22 Dec 2025
FDA approves Roche’s Lunsumio Velo for subcutaneous use in relapsed or refractory follicular lymphoma
22 December 2025 - Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which ...
Posted by Michael Wonder on 20 Dec 2025
Beren, through its subsidiary Mandos, submits new drug application to US FDA for adrabetadex in infantile-pnset NPC
19 December 2025 - Beren Therapeutics today announced that its subsidiary Mandos has submitted a new drug application to the US ...
Posted by Michael Wonder on 20 Dec 2025
Spero announces NDA resubmission of tebipenem hydrobromide by GSK to the FDA for the treatment of complicated urinary tract infections, including pyelonephritis
19 December 2025 - Spero Therapeutics today announced that its development partner, GSK, filed a new drug application resubmission to ...