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Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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myelodysplastic syndromes (MDS)
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FDA approves new therapy for myelodysplastic syndromes
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
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EMA validates MAA for novel telomerase inhibitor
Following European validation of its Marketing Authorisation Application (MAA), imetelstat has potential to become a standard of care in lower risk myelodysplastic syndromes (MDS), according to Geron’s CEO.
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First-in-class telomerase inhibitor aids transfusion independence in clinical trial
Telomerase inhibitor imetelstat benefitted both major subtypes of lower risk MDS in a Phase III trial for the first time.
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The promise of telomerase inhibitors for treating blood cancer
Geron’s CEO Chip Scarlett discusses the company’s leading telomerase inhibitor in this exclusive interview ahead of the 2022 American Society of Hematology Annual Meeting.
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New therapy for anaemic myelodysplastic cancer patients
Reblozyl, the first erythroid maturation agent showed increased haemoglobin in transfusion-dependant patients with myelodysplastic syndromes.
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Gilead and MacroGenics to develop bispecific cancer antibodies
A collaboration agreement between Gilead and biopharma company MacroGenics aims to develop MGD024, a bispecific antibody for treatment of blood cancers.
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Gates biomanufacturing facility announces agreement with Nkarta
The Gates Biomanufacturing Facility announced a strategic agreement with Nkarta to manufacture Nkarta's investigational cell therapy NKX101.
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Genetic fault reduces the effectiveness of leukaemia treatment
A genetic fault has been identified in people with an aggressive type of leukaemia that can significantly affect how they respond to treatment...
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Encouraging top-line results for APG101 in myelodysplastic syndromes
15 June 2016 | By Victoria White, Digital Content Producer
A Phase I trial showed that APG101 was well tolerated. In addition, the study showed that APG101 efficiently stimulates erythropoiesis in these patients...
