Recently, the US FDA has granted orphan drug status to two new therapeutics in a row. One is a small molecule inhibitor, PCLX-001, for the treatment of acute myeloid leukaemia; the other is a T-cell therapy, ET140203, for the treatment of hepatoblastoma. Both therapies are currently in relevant trials.
"FDA"
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The global ADC drug market will be approximately $5.2 billion by 2021
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Apparatus
Angry FDA & CDC: $5 Billion Bivalent Moderna New Crown Vaccine Not As Effective As Monovalent
Was the omission of key data intentional or unintentional?
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The FDA has granted accelerated approval to Adagrasib for the treatment of patients with KRAS G12C mutations in non-small cell lung cancer. In the trial, the drug resulted in disease control in 80% of patients, of which, 43% had substantial tumour shrinkage.
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Medical
New Treatment For Uroepithelial Carcinoma Receives Fda Fast Track Designation With Encouraging Initial Results
The FDA granted Fast Track designation to a new drug, IK-175, in combination with nabumab for the treatment of advanced uroepithelial carcinoma, after preliminary trial data showed encouraging and durable anti-tumor activity with a favorable safety profile.
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Apparatus
Fda Accepts Zuranolone's Nda Application And Grants It Priority Review For The Treatment Of Mdd And Pdd
Approval for new FIC depression drug on the horizon!
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Apparatus
New Targeted Drug For Leukaemia Approved, 35% Of Patients' Cancer Cells Disappear Completely!
The US FDA has approved a new leukaemia drug, Olutasidenib, which has been shown to be effective and has a controlled safety profile, resulting in the complete disappearance of cancer cells in 35% of patients enrolled, with efficacy lasting up to 25.9 months.
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Targeted drug Selpercatinib has received accelerated approval from the FDA. It is cancer-independent and may benefit any solid tumour with a positive RET gene fusion. It is up to 84% effective in selected patients with non-small cell lung cancer!
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The US FDA approved a new treatment for non-small cell lung cancer - Tremelimumab + Durvalumab + platinum-based chemotherapy. The triple combination therapy significantly improves efficacy and patient survival and has a good safety profile.
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The US FDA has accelerated the approval of the new drug Pirtobrutinib for the treatment of relapsed or refractory set of cell lymphomas. The drug led to substantial tumour disappearance in 50% of patients, with 13% of them having complete tumour disappearance.