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RSS FeedPosted by Michael Wonder on 12 Feb 2025
OnCusp Therapeutics receives FDA fast track designation for CUSP06 for the treatment of platinum-resistant ovarian cancer
12 February 2025 - OnCusp Therapeutics today announced that the US FDA has granted fast track designation to CUSP06, a cadherin-6 ...
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 12 Feb 2025
Factorial clinical trial designs
15 January 2025 - Clinical trials using factorial designs in which participants receive several randomised interventions simultaneously allow efficient evaluation of ...
Posted by Michael Wonder on 11 Feb 2025
Biohaven announces FDA acceptance and priority review of troriluzole new drug application for the treatment of spinocerebellar ataxia
11 February 2025 - Troriluzole demonstrated a 50-70% slowing of spinocerebellar ataxia disease progression on the primary and secondary outcome measures at ...
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 11 Feb 2025
Linvoseltamab BLA accepted for FDA review for the treatment of relapsed/refractory multiple myeloma
11 February 2025 - FDA decision expected by 10 July 2025. ...
Posted by Michael Wonder on 10 Feb 2025
Biodexa receives US FDA fast track designation for eRapa in familial adenomatous polyposis
10 February 2025 - Biodexa Pharmaceuticals announced today that the US FDA has granted fast track designation for eRapa, a proprietary ...
Posted by Michael Wonder on 10 Feb 2025
Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of moderate to severe atopic dermatitis
10 February 2025 - Nektar Therapeutics today announced that the US FDA has granted fast track designation for rezpegaldesleukin for the ...
Posted by Michael Wonder on 10 Feb 2025
Tempest granted fast track designation from the US FDA for amezalpat to treat patients with hepatocellular carcinoma
10 January 2025 - Tempest Therapeutics today announced that the US FDA has granted fast track designation to amezalpat (TPST-1120), an ...
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 07 Feb 2025
FDA grants priority review to Insmed's brensocatib for treatment of bronchiectasis
6 February 2025 - Brensocatib would be the first and only available treatment for bronchiectasis and first DPP1 inhibitor, if ...
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, ...
Posted by Michael Wonder on 05 Feb 2025
FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness
4 February 2025 - Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration, ...
Posted by Michael Wonder on 03 Feb 2025
US FDA accepts biologics license application for HLX11, biosimilar candidate of Perjeta (pertuzumab)
2 February 2025 - Shanghai Henlius Biotech announced that the US FDA has accepted the biologics license application for HLX11, ...