fda

FDA approves Roches Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase…

3 months ago

Press Release Biocartis NV: Biocartis Receives FDA Approval for the Idylla CDx MSI Test

PRESS RELEASE - 09/15/2025, 09:00 AM EDT Biocartis Receives FDA Approval for the Idylla™ CDx MSI Test First-ever fully automated,…

4 months ago

Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI IQLIK(lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimers Disease Under Fast Track Status

LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from…

4 months ago

Keros Announces U.S. FDA Orphan Drug Designation Granted to KER-065 for the Treatment of Duchenne Muscular Dystrophy

August 20, 2025 09:48 ET  | Source: Keros Therapeutics, Inc. LEXINGTON, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics,…

5 months ago

Ascentage Pharma Announces Global Registrational Phase III Study of Lisaftoclax for First-line Treatment of Patients with Higher-Risk Myelodysplastic Syndrome Cleared by US FDA and EMA

ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial…

5 months ago

Respiree Secures Second FDA 510(k) Clearance, Expands Cardio-Respiratory Wearable to Home Use via 1Bio Connected Care Platform

HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Respiree, a health tech company developing artificial intelligence (AI) platforms to…

5 months ago

Anbogen Receives FDA Clearance to Initiate Phase 1/2 Trial of ABT-301 Triplet Therapy for Advanced Colorectal Cancer

TAIPEI, Aug. 4, 2025 /PRNewswire/ -- Anbogen Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved…

5 months ago

Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity

HYDERABAD, India, August 1, 2025 /PRNewswire/ -- Zenara Pharma Private Limited ("Zenara"), a Biophore company, today announced that it has received final…

5 months ago

Leo Cancer Care Receives FDA 510(k) Clearance for Marie – A Revolutionary Upright Radiotherapy Platform

MIDDLETON, Wis., July 29, 2025 /PRNewswire/ -- Leo Cancer Care, a leader in upright radiotherapy solutions, today announces that its flagship…

5 months ago

Shanton Receives Fast Track Designation from US FDA for Refractory Gout Program

SAP-001 is Shanton's lead investigational compound with First- and Best-in-Class potential in uncontrolled gout SINGAPORE and PRINCETON, N.J., July 25,…

5 months ago