News about "FDA Approval"

FDA Grants Accelerated Approval to BeOne Medicines' Beqalzi for Relapsed Mantle Cell Lymphoma

BeOne Medicines has secured accelerated US FDA approval for Beqalzi (sonrotoclax) to treat relapsed or refractory mantle cell lymphoma, marking an advancement in targeted therapies for patients with limited treatment options.

FDA Approval | 16/05/2026 | By News Bureau

Axsome Therapeutics Secures US Food and Drug Administration Approval for Auvelity in Alzheimer's Agitation

First-in-class therapy approved to treat agitation linked to Alzheimer’s disease, addressing a major unmet need for patients and caregivers.

FDA Approval | 04/05/2026 | By News Bureau

FDA Approves Vanda Pharmaceuticals' BYSANTI as First-Line Therapy for Bipolar I Disorder and Schizophrenia

BYSANTI (milsaperidone), a new atypical antipsychotic from Vanda Pharmaceuticals, gains FDA approval for acute manic or mixed episodes in bipolar I disorder and schizophrenia in adults, with US launch planned for Q3 2026.

FDA Approval | 21/02/2026 | By News Bureau |  269

Novartis' Remibrutinib Shows Positive Phase III Results in Chronic Inducible Urticaria

Pivotal RemIND trial meets primary endpoint across three major CIndU subtypes, positioning oral remibrutinib as a potential first targeted therapy for inducible chronic hives.

FDA Approval | 19/02/2026 | By News Bureau |  225

D3 Bio Secures FDA IND Clearances to Advance KRAS G12D and KRAS G12C Oncology Programmes into Clinical Trials

D3 Bio has received FDA IND clearance to initiate a Phase I trial of its KRAS G12D inhibitor D3S-003 and a Phase II combination study targeting KRAS G12C-mutant lung cancer.

FDA Approval | 19/01/2026 | By News Bureau |  529

BD Secures FDA 510(k) Clearance for EnCor EnCompass Multi-Modality Breast Biopsy System

BD has received FDA 510(k) clearance for its EnCor EnCompass multi-modality breast biopsy system, designed to improve procedural efficiency, clinician flexibility and early detection and diagnosis of breast disease.

FDA Approval | 17/01/2026 | By News Bureau |  163

Leadoptik Secures FDA 510(k) Clearance for Last Inch Assessment System to Enhance Lung Biopsy Accuracy

The silicon photonics based imaging platform, Leadoptik’s LIA system, delivers real-time, high-resolution tissue insight at the point of care, addressing a critical gap in lung cancer diagnosis.

FDA Approval | 16/01/2026 | By News Bureau |  473

Medical Device Manufacturing Leader Esaote Secures FDA Clearance for Next-Gen MyLab Ultrasound Systems

Esaote, a global leader in medical device manufacturing specializing in ultrasound, dedicated MRI, and healthcare IT, announced that its MyLab A50 and MyLab A70 ultrasound systems have received FDA approval.

FDA Approval | 25/08/2025 | By Darshana |  252

EBR Systems Secures FDA Approval for WiSE System to Treat Advanced Heart Failure

Unlike conventional CRT, the WiSE System is the first and only to deliver leadless left ventricular endocardial pacing (LVEP), that closely aligns with the heart's natural conduction pathway.

FDA Approval | 19/04/2025 | By Abha |  530

Fapon Biopharma Receives FDA Approval of IND for FP008 for Solid Tumors

FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients.

FDA Approval | 03/03/2025 | By Aishwarya |  384