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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 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, ...
Posted by Michael Wonder on 02 Feb 2025
US FDA approves Celltrion's Avtozma (tocilizumab-anoh), a biosimilar to Actemra
30 January 2025 - Approval was received for multiple indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic ...
Posted by Michael Wonder on 01 Feb 2025
FDA approves novel non-opioid treatment for moderate to severe acute pain
30 January 2025 - First drug approved in new class of non-pioid pain medicines; agency continues to take steps to support ...
Posted by Michael Wonder on 31 Jan 2025
Axsome Therapeutics announces FDA approval of Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults
30 January 2025 - A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within ...
Posted by Michael Wonder on 30 Jan 2025
Vertex announces FDA approval of Journavx (suzetrigine), a first in class treatment for adults with moderate to severe acute pain
30 January 2025 - Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class ...
Posted by Michael Wonder on 30 Jan 2025
Ironwood Pharmaceuticals initiates apraglutide NDA submission
29 January 2025 - Initiated rolling new drug application submission, now to include long-term extension data given continued clinical improvement over ...