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RSS FeedPosted 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 11 Feb 2025
Immix Biopharma receives FDA regenerative medicine advanced therapy designation for NXC-201, sterically optimised CAR-T for relapsed/refractory AL amyloidosis
10 February 2025 - FDA RMAT designation follows positive proof of concept US clinical data from the NXC-201 NEXICART-2 clinical trial ...
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
Gradalis secures FDA regenerative medicine advanced therapy designation for Vigil (gemogenovatucel-T): an investigational personalised immunotherapy for advanced ovarian cancer
5 February 2025 - Recognising clinical evidence from the Phase 2b VITAL Study of Vigil in homologous recombination proficient patients with ...
Posted by Michael Wonder on 06 Feb 2025
Bracco Imaging receives FDA fast track designation for BR55, ultrasound molecular imaging agent for the detection of active bowel inflammation in Crohn's disease
6 February 2025 - BR55 is a contrast agent for ultrasound imaging targeted at a molecule expressed in angiogenesis, i.e., the ...
Posted by Michael Wonder on 06 Feb 2025
Acrivon Therapeutics announces FDA has granted breakthrough device designation for ACR-368 OncoSignature assay for endometrial cancer
5 February 2025 - The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in ...
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
Adicet Bio receives FDA fast track designation for ADI-001 for the treatment of refractory systemic lupus erythematosus with extra-renal involvement
5 February 2025 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the ...
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 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...