Myelodysplastic Syndromes

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Servier’s Tibsovo Opens The Door To A New Era In The Battle Against Myelodysplastic Syndromes

Servier’s Tibsovo (ivosidenib tablets) has received an expanded indication from the FDA, allowing its utilization in patients diagnosed with relapsed or refractory myelodysplastic syndromes that exhibit an IDH1 mutation. This new approval represents the fifth for Tibsovo, which is already recognized for its efficac...

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Myelodysplastic Syndrome Treatment Market: Unveiling the Robust Pipeline

The number of people diagnosed with myelodysplastic syndrome in the US each year is unknown. However, some estimates have put this number at about 10,000, while other estimates have been much higher. Moreover, myelodysplastic syndrome is uncommon before age 50, and the risk increases as a person gets older. It is a...

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Pharma News for Gilead, Ambrx, Mirati
Gilead’s Magrolimab Plus Azacitidine for MDS; FDA Approveds VANFLYTA for Newly Diagnosed AML; FDA Awards Fast Track Designation to ARX517 mCRPC; EMA Rejects Mirati’s Krazati; Harmony Phase III Pitolisant Trial for PWS Patients; Belite Bio’s Phase 3 DRAGON Trial of Tinlarebant for STGD

Gilead To Discontinue Phase III ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS Gilead Sciences, Inc. reported that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been halted due to futility based on a planned analysis. The safety data in this trial are consistent ...

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Pharma News for Actinium, Santhera, Gilead, Seres, BMS, Boehringer
Actinium Announces SIERRA Trial Results; Santhera Seeks FDA Review for Vamorolone; Seres Announces BLA Submission for SER-109; BMS Announces Results of COMMANDS Trial; Boehringer’s PDE4B Moves Late-stage Clinical Testing; FDA Rejects Gilead’s Hepcludex; Approval to J&J’s BCMAxCD3 Bispecific Antibody for Multiple Myeloma; Syncona to Acquire AGTC

Actinium Announces Positive Top-line Results from Pivotal Phase III SIERRA Trial of Iomab-B Actinium Pharma is on track to submit its targeted radiotherapy for AML patients requiring a bone marrow transplant in the United States, boosted by top-line data from a pivotal trial. The SIERRA trial of Iomab-B, an anti...

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Pharma News and Updates Precigen, Biogen, Cerevance, Sanofi, Clovis
Precigen’s PRGN-3006; Yescarta Approved as a First CAR T-cell Therapy for R/R LBCL; Biogen & Ionis’ BIIB078; Nobelpharma’s HYFTOR (sirolimus topical gel) 0.2%; Cerevance Parkinson’s Drug; Sanofi & Regeneron’s Dupixent; Clovis’s Rubraca for Ovarian Cancer; Immunocore Eye Cancer Cell Therapy Approval

FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R/R Large B-cell Lymphoma Until now, existing CAR-T therapies have been reserved for patients with blood cancer who have tried multiple treatments. The FDA has approved Yescarta, a CD19-directed CAR-T therapy developed by Gilead Science...

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Most Promising Oncological Drugs Expected to Launch in 2022

The innovation in the oncology drug pipeline has resulted in a record number of FDA and EU approvals in recent years, as investigators and sponsors seek new and targeted treatments for individuals diagnosed with different types of cancers each year. In 2022, regulators will continue to evaluate new oncology therapi...

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Myelodysplastic Syndrome Key Pharma Players
Myelodysplastic Syndromes (MDS): Key Pharma Players Unveiling Updated Findings at ASH 2021

There has been limited progress in the approval of novel agents in MDS. It has been a long wait since the last approval of lenalidomide (Revlimid) – only approved for 5–10% (del 5q) MDS patients – was granted 13 years back. Since then, only two other companies, Celgene and Astex Pharma; could succeed in getting app...

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Pharma news
Gilead to buy Forty Seven; Akrevia Therapeutics unveils new identity; FDA approved pyrimethamine

Gilead Sciences has announced to purchase an Immuno-oncology company Forty Seven for USD 95.50 per share, totalling up to a deal value of USD 4.9 billion. By acquiring Forty Seven – named after its lead molecule - CD47 tumor cell protein - Gilead will acquire its lead candidate, Magrolimab, adding value to its ...

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