Blog
RSS FeedPosted by Michael Wonder on 12 Jan 2026
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
12 January 2026 - Atara Biotherapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 08 Jan 2026
FDA approves new 2 gram presentation of Fibryga, enhancing convenience and precision in treating acquired fibrinogen deficiency
7 January 2026 - Octapharma today announced that the US FDA has approved a new 2 g presentation of Fibryga, fibrinogen ...
Posted by Michael Wonder on 01 Jan 2026
Corcept receives complete response letter for relacorilant as a treatment for patients with hypercortisolism
31 December 2025 - Corcept Therapeutics today announced that the US FDA has issued a complete response letter regarding the ...
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
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 ...