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…
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.,…
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…
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…
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…
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…
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…
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…
Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)
July 11, 2025 16:30 ET | Source: Ultragenyx Pharmaceutical Inc. Complete Response…
Sirtex Medical’s SIR-Spheres Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma
Expanded indication makes SIR-Spheres® the first and only radioembolization therapy in the…
