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RSS FeedPosted 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 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
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 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 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
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 16 Dec 2025
Historic first in women's sexual health: FDA grants approval for Addyi (flibanserin) in post-menopausal women
15 December 2025 - Sprout Pharmaceuticals today announced a monumental milestone for women's health: the US FDA has approved Addyi ...
Posted by Michael Wonder on 16 Dec 2025
US FDA approves LIB Therapeutics’ Lerochol (lerodalcibep-liga) for adults with elevated LDL-cholesterol
15 December 2025 - Lerochol expected to be available in the US in spring 2026. ...
Posted by Michael Wonder on 15 Dec 2025
FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer
15 December 2025 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) in combination with pertuzumab for the first-line ...
Posted by Michael Wonder on 15 Dec 2025
US FDA approves Daybue STIX (trofinetide) for oral solution, a new powder formulation, for Rett syndrome
15 December 2025 - Neuren Pharmaceuticals today announced that its partner Acadia Pharmaceuticals has received US FDA approval of Daybue ...