Blog
RSS FeedPosted 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 22 Dec 2025
Enhertu granted breakthrough therapy designation in the US as post-neo-adjuvant therapy for patients with HER2 positive early breast cancer
22 December 2025 - Tenth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast05 ...
Posted by Michael Wonder on 20 Dec 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted breakthrough therapy designation by the FDA for the treatment of PROC
20 December 2025 - Alphamab Oncology announced that the biparatopic HER2 targeting antibody drug conjugate JSKN003, independently by the US FDA ...
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
Cytokinetics announces FDA approval of Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms
19 December 2025 - FDA Approval based on results of SEQUOIA-HCM. ...
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 19 Dec 2025
BeOne Medicines granted US FDA fast track designation for BGB-B2033 as treatment for hepatocellular carcinoma
18 December 2025 - BGB-B2033 is a bispecific antibody directed at GPC3 and 4-1BB; key targets in the most common liver ...
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 18 Dec 2025
FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
17 December 2025 - Today, the FDA approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech) for subcutaneous injection for adult ...
Posted by Michael Wonder on 17 Dec 2025
FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
17 December 2025 - Today, the FDA approved rucaparib (Rubraca, pharmaand) for adults with a deleterious BRCA mutation (germline and/or ...