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RSS FeedPosted 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
Scilex announces approval of a new drug submission from the Health Canada for Elyxyb’s acute treatment of migraine with or without aura in Canada
15 April 2025 - Elyxyb is a first-line treatment and the only FDA approved, ready to use oral solution for the ...
Posted by Michael Wonder on 16 Apr 2025
Leqembi (lecanemab) is the first medicine that slows progression of early Alzheimer’s disease to be authorised in the European Union
15 Apil 2025 - Eisai and Biogen announced today that the European Commission has granted the amyloid-beta monoclonal antibody Leqembi (lecanemab) ...
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 15 Apr 2025
Health Canada approves Nduvra (tapinarof 1% cream) for the topical treatment of plaque psoriasis in adults
14 April 2025 - Organon today announced that Health Canada has approved Nduvra (tapinarof cream), 1%, the first in a novel ...
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 14 Apr 2025
European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy
14 April 2025 - Approval based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction ...
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
Health Canada approves Imfinzi (durvalumab) as the first and only immunotherapy regimen for adult patients with limited-stage small cell lung cancer
10 April 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab), as monotherapy, for the treatment ...
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 ...