Tuesday, March 17, 2026

AI Experts Call for Stronger Deepfake Regulation to Combat Misinformation

As generative AI technology-abused Deepfakes are ramping up on various social media platforms...

Inside North Korea’s Patriotic Push: High-Ranking Officials Visit War Heroes’ Homes

High-ranking officials in North Korea visited the homes of war veterans (Korean War veterans) to encourage them.

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.

Tag: FDA

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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.

GC Biopharma Corp Soars After Eight Years on the Back of Immunodeficiency Drug Alyglo, Posting Results in U.S. Market Push

GC Biopharma Corp breaks its fourth-quarter deficit with ALYGLO's success, achieving $106M in annual revenue and plans for future growth.

HM15275 Clinical Trials: What You Need to Know About This Groundbreaking Obesity Treatment

Hanmi Pharmaceutical's HM15275 enters Phase 2 trial, aiming to revolutionize obesity treatment and diabetes management by 2030.

Novo Nordisk’s Oral Wegovy Tops 3,000 Prescriptions in Its First Week—A Challenge to Injectable GLP-1s

Novo Nordisk's Wegovy oral treatment exceeds 3,000 prescriptions in its debut week, signaling a shift towards oral obesity medications.

Novo Nordisk’s Wegovy Pill Draws 3,000 Prescriptions in Its First Week—Is Oral GLP-1 Here to Stay?

Novo Nordisk's Wegovy oral obesity treatment saw over 3,000 prescriptions in its first week, indicating strong market demand.

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