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News about "FDA Approval"
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 | 210
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 | 101
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 | 226
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 | 203
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 | 375
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 | 327
Nexus Pharmaceuticals Secures FDA Approval for Tacrolimus Injection
Tacrolimus Injection 5 mg/mL (Single-Dose Vial) in a 10-pack will be launching soon.
FDA Approval | 15/02/2025 | By Aishwarya | 390
American Injectables Secures FDA Approval
American Injectables, specialising in sterile injectables, has announced that it has received FDA approval.
FDA Approval | 10/01/2025 | By Abha | 385
Alembic Pharma Secures FDA Approval for Diltiazem Hydrochloride Capsules
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Dilacor XR Extended-Release Capsules, 120 mg, 180 mg, and 240 mg, of Allergan Sales LLC (Allergan).
FDA Approval | 21/10/2024 | By Aishwarya | 752
Alembic Pharma Gets FDA Approval for Lamotrigine Extended-Release Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK).
FDA Approval | 07/10/2024 | By Aishwarya | 641
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