Blog
RSS FeedPosted 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 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 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 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 ...
Posted by Michael Wonder on 20 Dec 2025
Hansa Biopharma submits BLA to FDA for imlifidase in desensitisation for kidney transplantation
19 December 2025 - The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in ...
Posted by Michael Wonder on 20 Dec 2025
US FDA approves Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults
19 December 2025 - Boehringer Ingelheim’s Jascayd (nerandomilast) tablets has been approved by the US FDA for the treatment of progressive ...
Posted by Michael Wonder on 20 Dec 2025
FDA grants two national priority vouchers
19 December 2025 - The US FDA today awarded national priority vouchers under the Commissioner’s National Priority Voucher pilot program ...
Posted by Michael Wonder on 19 Dec 2025
Egetis Therapeutics initiates new drug application in the USA for Emcitate (tiratricol) for MCT8 deficiency
19 December 2025 - Egetis Therapeutics today announced that the Company has initiated a rolling new drug application submission to ...
Posted by Michael Wonder on 19 Dec 2025
Sangamo Therapeutics initiates rolling submission of BLA to US FDA for ST-920 in Fabry disease
18 December 2025 - Sangamo expects to complete biological license application submission under accelerated approval pathway in second quarter of ...
Posted by Michael Wonder on 18 Dec 2025
Novo Nordisk files for FDA approval of CagriSema, the first onceweekly combination of GLP‑1 and amylin analogues for weight management
18 December 2025 - – Today, Novo Nordisk announced the submission of a new drug application to the US FDA ...
Posted by Michael Wonder on 17 Dec 2025
Vanda announces submission of biologics license application to the FDA for imsidolimab for the treatment of generalised pustular psoriasis
15 December 2025 - Vanda Pharmaceuticals today announced the submission of a biologics license application to the US FDA) for ...