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RSS FeedPosted 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 ...
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 ...
Posted by Michael Wonder on 17 Dec 2025
Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma
16 December 2025 - Approval based on SWIFT trials showing significantly lower rate of annualised asthma exacerbations in patients receiving depemokimab ...
Posted by Michael Wonder on 17 Dec 2025
FDA eliminates major barrier to using real world evidence in drug and device application reviews
15 December 2025 - The US FDA today removed a key limitation on the use of real world evidence used in ...
Posted by Michael Wonder on 16 Dec 2025
Palvella Therapeutics granted FDA fast track designation for Qtorin 3.9% rapamycin anhydrous gel for the treatment of angiokeratomas
16 December 2025 - Angiokeratomas are characterised by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality of ...