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ITM
NEWS

ITM Reports the US FDA’s NDA Acceptance for ¹⁷⁷Lu-edotreotide to Treat Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Shots: The US FDA has accepted an NDA of 177Lu-edotreotide (ITM-11) for the treatment of GEP-NETs, with a PDUFA goal date of Aug 28, 2026 NDA was supported by the P-III (COMPETE) trial assessing ITM-11 vs everolimus (N=309) as a 1/2L treatment of inoperable, progressive, SSTR+ Grade 1 or 2 GEP-NETs, which met its 1EP of…
November 13, 2025

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NEWS

Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis

Shots: Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT Analyser & Immunoglobulin Isotypes (GAM) Assay, an automated mass spectrometry-based platform, for aiding diagnosis of MM & related conditions The EXENT System detects & isotypes low-concentration M-proteins with high sensitivity to identify them by molecular weight, differentiating endogenous from therapeutic antibodies & providing…
November 13, 2025

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NEWS

Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved OncoMate MSI Dx Analysis System as a companion diagnostic to identify pts with microsatellite stable endometrial carcinoma The OncoMate MSI Dx Analysis System is a PCR-based assay that determines MSI status in tumors to identify pts eligible for treatment with Keytruda (pembrolizumab) & Lenvima (lenvatinib) OncoMate MSI Dx Analysis System…
November 12, 2025

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NEWS

March Biosciences’ MB-105 Receives the Regenerative Medicine Advanced Therapy Designation for R/R CD5+ T-Cell Lymphoma

Shots: The US FDA has granted RMAT designation to MB-105 for the treatment of r/r CD5-positive T-cell lymphoma Designation was based on the ongoing P-II trial, which showed clinical activity with a favorable safety profile; initial data to be presented at ASH’25, with additional updates expected in 2026 March Bio will pursue clinical & commercial…
November 12, 2025

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Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder

Shots: The US FDA has approved Caplyta as an adjunctive therapy with antidepressants for treating adults with major depressive disorder (MDD). An sNDA for schizophrenia relapse prevention is also submitted Approval was based on 2 P-III (Study 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant in MDD pts Trial…
November 7, 2025

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Johnson& Johnson
NEWS

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

Shots: FDA has approved Darzalex Faspro (daratumumab & hyaluronidase-fihj) for high‑risk SMM based on the P-III (AQUILA) study assessing Darzalex Faspro alone vs active monitoring in adults, which met its 1EP of improved PFS by 51%, with 63.1% vs 40.7% pts progression-free at a mFU of 65.2mos. Trial also showed an improved ORR (63.4% vs…
November 7, 2025

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NEWS

Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes

Shots: Aqua Medical has received the US FDA IDE approval to initiate the RESTORE-1 study evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure using its radiofrequency vapor ablation (RFVA) system in adults with uncontrolled type 2 diabetes The IDE approval was backed by international data showing safety & metabolic benefits of PIMA, allowing Aqua Medical…
November 6, 2025

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