Prostate Cancer
Nov 14, 2023
Takeda’s ADZYNMA Approved by FDA; AskBio Presents Preliminary Data from Phase I Trial of Gene Therapy for CHF; Bayer’s Aflibercept 8 mg Recommended for Approval in EU; FDA Orphan Drug Designation to MAIA Biotechnology’s THIO; First Patient Dosed in Phase III ProstACT GLOBAL Study; FDA Grants Orphan Designation for Lipella’s LP-310 Drug Candidate
Takeda’s ADZYNMA Approved by FDA as the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura Takeda has received FDA approval for ADZYNMA (ADAMTS13, recombinant-krhn) for both prophylactic and on-demand treatment in adults and pediatri...
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Oct 31, 2023
Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC
FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...
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Aug 15, 2023
J&J’s 2-in-1 Tablet for Prostate Cancer; FDA Approves TALVEY for Heavily Pretreated Multiple Myeloma; PDS Biotech Updated on VERSATILE-003 Trial; FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in HNC; FDA Orphan Drug Designation to Genprex’s REQORSA; FDA Orphan Drug Designation to Bloomsbury’s BGT-OTCD
FDA Clears J&J’s 2-in-1 Tablet for Prostate Cancer Johnson & Johnson's Janssen Pharmaceutical Companies stated that the US Food and Drug Administration (FDA) had approved AKEEGA (niraparib and abiraterone acetate), the first-and-only dual-action tablet combining a PARP inhibitor including abiraterone ace...
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Jul 27, 2023
VARON’s New VP Series Portable Oxygen Concentrator; Biostrap’s Wrist-Worn Digital Health Monitoring Device; MediView’s AR Navigation Platform; Beckman Coulter’s DxC 500 AU Chemistry Analyzer; Magnus Updated on Study Using SAINT Neuromodulation System; Francis Medical’s VAPOR 2 Pivotal Study
VARON Launched the Game-changer in the Field--New VP Series Portable Oxygen Concentrator On July 19, 2023, VARON, a leading oxygen concentrator manufacturer, announced the launch of a game-changer portable oxygen concentrator VP-2. A new member of the VP series, VP-2 is incorporated with innovative tech...
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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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Feb 24, 2023
A Quick Recap from ASCO GU 2023: Prostate and Urothelial Cancer Highlights
The ASCO Genitourinary (GU) Cancers Symposium, which ended on February 18, 2023, was a three-day scientific and educational meeting designed to provide attendees with in-depth, multidisciplinary analysis of the timely topics in the study, diagnosis, and treatment of GU malignancies. DelveInsight has compiled the sy...
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Feb 07, 2023
Merck’s Keytruda Wins Another FDA Approval; Sanofi Pauses Trial of Myasthenia Gravis Drug, tolebrutinib; FDA Approves GlaxoSmithKline’s Jesduvroq; FDA IND Application Clearance for Hinova’s HP518; FDA Fast Track Designation to Endogena’s EA-2353; Amylyx Updates on Global Phase 3 PHOENIX Trial
Merck Wins Another FDA Approval for Blockbuster Keytruda Merck & Co arrived just two months after GSK celebrated a positive phase III result with its checkpoint inhibitor Jemperli as a first-line therapy for endometrial cancer. Keytruda (pembrolizumab) from Merck improved progression-free survival (PFS) vers...
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Aug 25, 2022
Edwards’s Pascal Precision System; Abbott’s New Spinal Cord Stimulation Device; Imagin to Acquire enCAGE Coil Precision Ablation System; Boston Heart Diagnostics Launches LipidSeqTM; Rocket VR Health Partners with Penn Medicine’s Abramson Cancer Center; Thermedical’s Clinical Trial to Treat Ventricular Tachycardia
Edwards Pascal Precision Transcatheter Mitral And Tricuspid Valve Repair System Receives CE Mark On August 17, 2022, Edwards Lifesciences Corporation, an American medical technology company headquartered in Irvine, California, specializes in artificial heart valves and hemodynamic monitoring. The company announc...
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Aug 23, 2022
EMA to review Cidara Therapeutics’ Rezafungin; EU Approves Gilead Sciences’ Sunlenca; FDA Approves Axsome’s Auvelity; EU Marketing Authorisation to Oncopeptides’s Pepaxti; Merck Signs $ 3.5 B Deal with Orna; FDA to review AstraZeneca and Merck’s Lynparza; FDA Approval to Bluebird’s Zynteglo; FDA Decision Date for GSK’s Momelotinib
EU Regulator Starts its Review of Cidara Therapeutics’ Candidiasis Therapy Rezafungin The EU regulator has begun its review of Cidara Therapeutics’ once-weekly antifungal rezafungin, with a decision expected next year as a new option for serious, invasive candida infections. The application is based on the ReSTO...
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Aug 16, 2022
Novartis’ Canakinumab for NSCLC; Novartis’s Zolgensma Updates; Trodelvy Prospects in New Breast Cancer Use; Novartis Secures European Approval For Pluvicto; Bristol-Myers Squibb’s Abecma Phase III Trials; Trastuzumab Approved for Deruxtecan for HER2-Mutant NSCLC
Novartis’ Canakinumab Fails in Phase III Trials for NSCLC Canakinumab's prospects as an anticancer therapy were already dwindling when a third phase III trial in non-small cell lung cancer (NSCLC) failed to reach its objectives. The most recent setback came from the CANOPY-A study, which included patients with N...
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