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RSS FeedPosted by Michael Wonder on 17 Apr 2025
uniQure announces FDA breakthrough therapy designation granted to AMT-130 for the treatment of Huntington’s disease
17 April 2025 - Breakthrough therapy designation based on clinical evidence from Phase I/II trials showing meaningful slowing of disease progression. ...
Posted by Michael Wonder on 17 Apr 2025
Eylea HD (aflibercept) injection 8 mg sBLA accepted for FDA priority review for both the treatment of macular oedema following retinal vein occlusion and for monthly dosing in approved indications
17 April 2025 - If approved, Eylea HD would be the first and only treatment for RVO indicated for up to ...
Posted by Michael Wonder on 17 Apr 2025
Neurelis announces FDA approval for immediate use seizure medication Valtoco (diazepam nasal spray) in age 2 to 5
16 April 2025 - Valtoco maintains orphan drug exclusivity for Valtoco to treat episodes of frequent seizures. ...
Posted by Michael Wonder on 16 Apr 2025
FDA grants fast track status to Prescient’s PTX-100, advancing commercialisation pathway
16 April 2025 - Prescient Therapeutics has received fast track designation from the US FDA for its lead candidate PTX-100, ...
Posted by Michael Wonder on 16 Apr 2025
Fate Therapeutics receives regenerative medicine advanced therapy designation from FDA for FT819 to treat moderate to severe systemic lupus erythematosus
14 April 2025 - Fate Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to FT819, an ...
Posted by Michael Wonder on 16 Apr 2025
US FDA grants interchangeable designation to Yuflyma (adalimumab-aaty), Celltrion's biosimilar to Humira (adalimumab)
14 April 2025 - Interchangeable designation of Yuflyma is supported by positive data from the Phase 3 interchangeability study in ...
Posted by Michael Wonder on 15 Apr 2025
Precision BioSciences receives US FDA fast track designation for PBGENE-HBV, a first in class gene editing therapy designed to eliminate the root cause of chronic hepatitis B
15 April 2025 - Precision BioSciences today announced that the US FDA has granted fast track designation for PBGENE-HBV, the Company’s ...
Posted by Michael Wonder on 14 Apr 2025
SynOx Therapeutics receives fast track designation from US FDA for emactuzumab for tenosynovial giant cell tumours
14 April 2025 - SynOx Therapeutics today announced that the US FDA has granted fast track designation to emactuzumab for the ...
Posted by Michael Wonder on 11 Apr 2025
Verve Therapeutics receives US FDA fast track designation for VERVE-102, an in vivo base editing medicine targeting PCSK9
11 April 2025 - Verve Therapeutics today announced that the US FDA has granted fast track designation for VERVE-102 for ...
Posted by Michael Wonder on 11 Apr 2025
FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma
11 April 2025 - Today, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, ...
Posted by Michael Wonder on 11 Apr 2025
US FDA grants full approval of Vitrakvi (larotrectinib) for adult and paediatric patients with NTRK gene fusion-positive solid tumours
10 April 2025 - The full approval of Vitrakvi is based on the results of confirmatory trials that support Vitrakvi as ...
Posted by Michael Wonder on 11 Apr 2025
argenx announces FDA approval of Vyvgart Hytrulo pre-filled syringe for self-injection in generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy
10 April 2025 - Self-injection provides generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy patients with flexibility for when and where to receive ...
Posted by Michael Wonder on 11 Apr 2025
Biocon Biologics announces US FDA approval for Jobevne, biosimilar bevacizumab
10 April 2025 - Biocon Biologics today announced that the US FDA has approved Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for ...
Posted by Michael Wonder on 10 Apr 2025
Arcturus Therapeutics receives US FDA fast track designation for the STARR mRNA vaccine candidate ARCT-2304 for pandemic influenza A virus H5N1
10 April 2025 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation for the self-amplifying mRNA ...
Posted by Michael Wonder on 09 Apr 2025
Outlook Therapeutics announces acceptance of biologics license application by US FDA for ONS-5010 as a treatment for wet AMD
8 April 2025 - PDUFA goal date of 27 August 2025. ...