Saturday, May 2, 2026

SM Entertainment Marks 30th Anniversary with Star-Studded Album Release

SM Entertainment celebrates its 30th anniversary with 2025 SMTOWN: THE CULTURE, THE FUTURE, featuring 17 tracks from 14 artists.

The Astronomical Salaries of NVIDIA Employees

According to a report by the Wall...

Luxury Snowmobiles Seen at North Korea’s Masikryong Ski Resort in Violation of Sanctions, Worth More Than $10,000

Expensive snowmobile equipment, which is subject to...

Tag: FDA

North KoreaKoreaKimMilitarySouth KoreaAImarketrelationsInternational

JLK Secures FDA Clearance for Stroke Analysis Solution… Advancing Clinical Workflow

JLK's "JLK-NCCT" receives FDA clearance for AI-based stroke analysis, enhancing early detection and triage in emergency settings.

2026년 바이오의약품 안전관리: 이상사례 과학적 분석의 모든 것

The FDA enhances adverse event evaluation and guides healthcare providers on self-injectable medications for patient safety.

Unlocking Cancer Treatment: ABL206 and ABL209’s Promising Non-Clinical Data Revealed at AACR

ABL Bio will present preclinical data for its ADCs ABL206 and ABL209 at AACR 2023, showcasing promising anti-cancer efficacy.

Unlocking Treatment Potential: GI-102 and Pasritamig Clinical Trial Insights

GI Innovation has filed an IND application for a clinical trial on a combination therapy for metastatic prostate cancer in South Korea and the U.S.

How Celltrion Plans to Cut Biologics Development Costs by 25% Amid FDA Regulation Changes

Celltrion is optimistic about enhanced competitiveness due to eased biosimilar regulations by the FDA, expecting significant cost reductions.

Celltrion’s CT-P55: What Changes to FDA Clinical Trials Mean for Biosimilarity with Cosentyx?

Celltrion has applied to the FDA for changes to its Phase 3 trial of CT-P55, reducing participants to 153 to assess biosimilarity to Cosentyx.

Alteogen Secures U.S. Patent for Keytruda Subcutaneous Injection: What This Means for ALT-B4 and Future Treatments

Alteogen secures a U.S. patent for a subcutaneous Keytruda formulation using ALT-B4, ensuring exclusivity until 2043 and potential $1B in sales.

Verismo Therapeutics Welcomes FDA Approval Expert Dennis Williams: What This Means for CAR-T Cell Therapy

HLB Innovation appoints Dr. Dennis Williams as VP of Regulatory Affairs at Verismo Therapeutics to enhance global regulatory strategies.

CGBio’s NovoFactory: A Game-Changer for Bone Graft Products in the U.S. and Japan

CGBio's new Novo Factory in Hwaseong receives approval to produce Novosis Putty, targeting advanced markets like the U.S. and Japan.

A New Adult Pneumococcal Shot Hits Korea: 21-Valent Coverage Targeting 80% of Adult Invasive Cases

Korean MSD launches Capvaxive, a 21-valent vaccine for adults to prevent pneumococcal diseases, targeting high-risk populations.

ABL209 Receives FDA Approval: What This Dual Antibody ADC Means for Cancer Treatment

ABL Bio receives FDA approval for ABL209, a bispecific antibody-drug conjugate, advancing ADC development for solid tumors.

A New Hair-Growth Pathway?: JW0061 Targets GFRA1 After 7.2x Organoid Results and a 39% Animal Boost

JW Pharmaceutical's hair loss treatment JW0061 gains FDA approval for clinical trials, promising innovative growth stimulation for men and women.

Korean Medical AI Lands at the University of Washington: Neurofit Signs U.S. Deal for Brain MRI + PET Analysis Tools

Neurofit signs a contract to supply AI medical solutions to the University of Washington, marking its U.S. market entry and expansion.

FDA Grants Breakthrough Therapy Designation to Hanmi’s Epheglucagon: What This Means for Rare Disease Treatment

Hanmi Pharmaceutical's efpegerglucagon receives FDA Breakthrough Therapy designation for treating rare Congenital Hyperinsulinism, with Phase 2 results due soon.

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