Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2025
Celltrion receives US FDA approval for Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) biosimilars referencing Prolia and Xgeva
3 March 2025 - The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the ...
Posted by Michael Wonder on 03 Mar 2025
FDA approves Genentech’s TNKase in acute ischaemic stroke in adults
3 March 2025 - TNKase (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years. ...
Posted by Michael Wonder on 28 Feb 2025
FDA approves Odactra for the treatment of house dust mite allergy in young children
27 February 2025 - ALK today announced that the US FDA has approved ALK’s Odactra tablet for use in young children ...
Posted by Michael Wonder on 21 Feb 2025
FDA approves first treatment for cerebrotendinous xanthomatosis, a rare lipid storage disease
21 February 2025 - Today, the US FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis in adults. ...
Posted by Michael Wonder on 16 Feb 2025
Bavarian Nordic receives US FDA approval of chikungunya vaccine for persons aged 12 and older
14 February 2025 - On track for commercial launch in the US in the first half of 2025. ...
Posted by Michael Wonder on 16 Feb 2025
FDA approves Samsung Bioepis’ Ospomyv, Xbryk (denosumab-dssb), a biosimilar to Prolia and Xgeva
15 February 2025 - Samsung Bioepis’ first endocrinology biosimilar to be approved by the FDA – widening its therapeutic areas and ...
Posted by Michael Wonder on 15 Feb 2025
Penmenvy, GSK’s 5 in 1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY
15 February 2025 - Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes
14 February 2025 - Agency continues efforts to increase access to insulin treatment options. ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves vimseltinib for symptomatic tenosynovial giant cell tumour
14 February 2025 - Today, the FDA approved vimseltinib (Romvimza, Deciphera Pharmaceuticals), a kinase inhibitor, for adult patients with symptomatic ...
Posted by Michael Wonder on 13 Feb 2025
US FDA approves expanded label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
12 February 2025 - Izervay dosing approved beyond 12 months. ...
Posted by Michael Wonder on 12 Feb 2025
FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
12 February 2025 - On 11 February 2025, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with lenalidomide and a ...
Posted by Michael Wonder on 11 Feb 2025
FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
11 February 2025 - Today, the FDA approved mirdametinib (Gomekli, SpringWorks Therapeutics), a kinase inhibitor, for adult and paediatric patients ...
Posted by Michael Wonder on 07 Feb 2025
US FDA approves Emblaveo (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options
7 February 2025 - Emblaveo is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the US FDA to ...
Posted by Michael Wonder on 06 Feb 2025
FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and paediatric patients with AML or MDS
21 January 2025 - Today, the FDA approved treosulfan (Grafapex, medac), an alkylating agent, with fludarabine as a preparative regimen ...
Posted by Michael Wonder on 06 Feb 2025
Supernus announces FDA approval of Onapgo (apomorphine hydrochloride) for Parkinson’s disease
4 February 2025 - Supernus Pharmaceuticals announced today that the US FDA approved Onapgo (apomorphine hydrochloride) injection, formerly known as SPN-830, ...