Acute Myeloid Leukemia
Oct 17, 2023
Novo Nordisk to Acquire Ocedurenone; FDA Awards Orphan Drug Designation to SLS009 in AML; FDA Approves Adjuvant Nivolumab in Completely Resected Stage IIB/C Melanoma; Fast Track Designation to South Rampart Pharma’s SRP-001; TAGRISSO + Chemotherapy Granted Priority Review in the US; Fast Track Designation to SurVaxM for Glioblastoma
South Rampart Pharma Receives U.S. FDA Fast Track Designation for SRP-001 for Acute Pain On October 12, 2023, South Rampart Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track status to its drug candidate, SRP-001, intended for the management of acute pain. SRP-001 is a...
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Sep 05, 2023
Daiichi Sankyo’s Trastuzumab Deruxtecan; ODD to Bexmarilimab for AML; Roche’ Alecensa; Ergomed Aims To Go Private; Tagraxofusp Receives ODD in Japan for BPCDN; FDA Fast Track Designation to Abliva’s KL1333
FDA Grants Breakthrough Therapy Designations to Trastuzumab Deruxtecan for HER2+ Solid Tumors, Including mCRC ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the United States for the treatment of adult patients with unresectable or metastati...
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Aug 29, 2023
FDA Approves BMS’s Reblozyl for MDS; FDA Awards Orphan Drug Designation to NXC-201; Janssen Submits Supplemental NDA for Full Approval of BALVERSA; FDA Grants Fast Track Status to ALE.C04; FDA Orphan Drug Designation to Faron’s Bexmarilimab; FDA Clears IND Application for AHB-137
FDA Approves Bristol Myers Squibb’s Reblozyl as First-Line Treatment of Anemia in Adults with Lower-Risk MDS Who May Require Transfusions Bristol Myers Squibb announced that the Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia in adult patients with very l...
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Aug 22, 2023
Eylea HD Injection 8 Mg Approved By FDA; Veopoz Receives FDA Approval for CHAPLE Disease Treatment; FDA Places Second Partial Clinical Hold on AML Enrollment for Magrolimab Trials; FDA Approval to Incannex’s Sleep Apnoea Clinical Trial; FDA Orphan Drug Designation to Avidity’s AOC 1044; Orphan Drug Designation to CanariaBio’s MAb-AR20.5
Eylea HD Injection 8 Mg Approved By FDA for Treatment of Wet AMD, DME, and Diabetic Retinopathy The FDA has approved Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection of 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retin...
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Jul 25, 2023
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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Jul 11, 2023
FDA Grants Priority Review for Zolbetuximab BLA; FDA Traditional Approval for LEQEMBI for Alzheimer’s Disease; Iovance Announces Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC; Biophytis Seeks FDA Approval to Launch Phase 3 Study of Potential Treatment of Sarcopenia; Orphan Drug Designation to Marker Therapeutics’s MT-401 for AML Treatment; Axsome Therapeutics Initiates Phase 3 Trial of Solriamfetol for ADHD
Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-target...
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Jun 13, 2023
FDA Fast Track Status to Kyverna’s KYV-101; Annovis’s Phase III Study for Buntanetap; Gilteritinib Demonstrated Benefit in AML Patients; FDA Orphan Drug Designation to DTx Pharma’s DTx-1252; FibroGen’s LELANTOS-1 Phase 3 Clinical Study Result
FDA Grants Fast Track Status to KYV-101 for Refractory Lupus Nephritis Treatment Kyverna Therapeutics announced that the FDA has given Fast Track status to KYV-101, a treatment for patients suffering from resistant lupus nephritis (LN). KYV-101 is an innovative therapy that uses anti-CD19 chimeric antigen recept...
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Mar 21, 2023
AbbVie Announces Results of Study Evaluating SKYRIZI; FDA Fast Track Designation to Arrowhead’s ARO-APOC3; FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Low-Grade Glioma; FDA Grants ODD to Novel BRAF Inhibitor for Brain/CNS Malignancies; EP0042 Wins FDA Orphan Drug Status; Karuna Therapeutics Announces Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia
AbbVie Announces Positive Results of Study Evaluating SKYRIZI in Plaque Psoriasis Patients AbbVie announced new 52-week data from an open-label, a single-arm study demonstrating improved plaque psoriasis signs and symptoms in a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 ...
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Feb 21, 2023
Actinium Announces Phase III SIERRA Trial Results; FDA Approves Apellis’s Geographic Atrophy Drug; FDA Gives Green Light to Chiesi’s Lamzede; FDA Accepts NDA and Grants Priority Review for Avacincaptad Pegol; FDA Approves Travere’s Kidney Disorder Drug; Takeda Presents Phase 3 GRAPHITE Study Results
Actinium Announces Positive Full Data Results From the Pivotal Phase III SIERRA Trial Actinium Pharmaceuticals, Inc., a pioneer in the development of targeted radiotherapies, announced positive primary and secondary endpoint results from its pivotal Phase III SIERRA trial of Iomab-B in patients aged 55 and older...
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Dec 06, 2022
Nkarta’s Anti-CD19 Allogeneic CAR-NK Cell Therapy, NKX019; Eisai Presents Results of lecanemab for Alzheimer’s Disease; EQRx’s Aumolertinib for EGFR-Mutated NSCLC; FDA Approves Olutasidenib for IDH1-Mutated R/R AML; FDA Orphan Drug Designation to AUM302 for Neuroblastoma; X4 Pharma Announces Results for WHIM Syndrome Drug
FDA Grants Orphan Drug Designation to AUM302 for Neuroblastoma A global clinical-stage biotech company, AUM Biosciences, focused on discovering and developing precision oncology therapeutics, declared that the U.S. FDA has permitted Orphan Drug Designation for AUM302. For the treatment of neuroblastoma, AUM302 i...
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