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Briefing

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HLB’s Ripaxtu Wins Full FDA Approval, Marking First Step in Direct Commercialization for K-Biotech

B· Original

HLB’s Ripaxtu Wins Full FDA Approval, Marking First Step in Direct Commercialization for K-Biotech

Domestic company secures global rights and independently takes drug from late-stage trials through approval Full approval based on single-arm trial marks an unusual FDA regulatory innovation

HLB Affiliate Wins First FDA Approval for a Drug Developed by a Korean Company: Bile Duct Cancer Treatment

HLB Affiliate Wins First FDA Approval for a Drug Developed by a Korean Company: Bile Duct Cancer Treatment

Biotech’s “Go Nordic Project” Gets Underway

Biotech’s “Go Nordic Project” Gets Underway

Liver Cancer’s Stem Cell Traits and Drug Resistance Driven by p38β

Liver Cancer’s Stem Cell Traits and Drug Resistance Driven by p38β

AZ-BMS Megadeal: A $4.2 Trillion Oncology Giant and Trump-Era Antitrust Risk

AZ-BMS Megadeal: A $4.2 Trillion Oncology Giant and Trump-Era Antitrust Risk

Bio News

Aspen Neuroscience and Bambusa Plan U.S. IPOs; Developers of Parkinson’s and Bispecific Antibody Therapies

St. Jude Identifies Cell Marker for High-Risk Neuroblastoma

University of Texas at Austin Develops Flexible Electrode for Recording Brain Waves for a Month Without Shaving Hair

Briefing

ViOL Medical Wins Thai Approval for HIFU Device, Laying Groundwork for Consumables Revenue

SCD Pharm’s glaucoma drug Latast reaches 11% market share, supplied back to originator

Alteogen’s ALT-B4 Infringes Halozyme Patent in Europe; Keytruda SC Sales Banned in 8 Countries

Immunology Drug Developer TrexBio Prices $117 Million IPO

CKD’s third-generation Lee Ju-won becomes second-largest shareholder as new drug R&D faces a test

HLB Makes Fourth Bid for Liver Cancer Drug Approval; Uncertainty Remains Despite Less Severe Inspection Outcome

Popular

Peptone nears end of two-year Lilly technology evaluation…follow-on deal could be pivotal

Peptone nears end of two-year Lilly technology evaluation…follow-on deal could be pivotal

HLB Pharmaceutical Completes 60.8 Billion Won Rights Offering, Bets on New Hyangnam Plant as Management Participation Grows

HLB Pharmaceutical Completes 60.8 Billion Won Rights Offering, Bets on New Hyangnam Plant as Management Participation Grows

Song Young-sook sells 86 billion won stake; buyer is daughter’s one-person company — Is a second round of Hanmi control battle looming?

Song Young-sook sells 86 billion won stake; buyer is daughter’s one-person company — Is a second round of Hanmi control battle looming?