application

Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy

Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgANORIGIN Phase 3 trial met its primary endpoint at the…

4 weeks ago

Alvotech Provides Update on the Status ofU.S. Biologics License Application for AVT05

REYKJAVIK, Iceland, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and…

1 month ago

Junshi Biosciences Announces FDAs Approval of IND Application for Phase 2/3 Clinical Study of JS207 for the Neoadjuvant Treatment of NSCLC Patients

SHANGHAI, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading…

2 months ago

Bybit Kazakhstan Launches Pilot for QR-Based Digital Asset Payments as NBK Sandbox Application Progresses

DUBAI, UAE, Sept. 29, 2025 /PRNewswire/ -- Bybit Limited (Bybit Kazakhstan), a crypto exchange licensed by the Astana Financial Services…

2 months ago

Oliva launches GeneIQ – India’s First DNA-Based Derma Clinic Application

Over 130 genes and 150 traits analysed to provide personalised skin careGeneIQ – India's first medico-aesthetic clinic application reinforces our…

2 months ago

Opterion Health AG submits Clinical Trial Application for First-in-Human Study of OPT101 in Patients with Advanced Chronic Kidney Disease

MUTTENZ, Switzerland, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Opterion Health AG, a clinical-stage biopharmaceutical company developing OPT101 as an innovative…

3 months ago

Imaging Endpoints Announces Patent Application for AI Review Charter System

SCOTTSDALE, Ariz., Sept. 10, 2025 /PRNewswire/ -- Imaging Endpoints (IE), the global leader in Imaging CRO technologies and services for…

3 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…

3 months ago

DXC Named a Leader in Everest Group’s Custom Application Development Services PEAK Matrix Assessment 2025 Report

Report highlights DXC's strengths leveraging GenAI platforms, equipping software engineers with secure AI-powered assets and services to accelerate software development.…

4 months ago

KuCoin TR Submitted SPK Application in Trkiye, Affirming Commitment to Compliance and Local Users

ISTANBUL, Aug. 7, 2025 /PRNewswire/ -- KuCoin, a leading global cryptocurrency exchange, is pleased to announce that its Türkiye collaborative…

4 months ago