Search results for "U.S."

Beyond FDA Clearance: 'MedTech Insight 2026' Navigates U.S. Hospital Procurement and Global Market Access

Beyond FDA Clearance: 'MedTech Insight 2026' Navigates U.S. Hospital Procurement and Global Market Access

Securing regulatory clearance for a medical device in overseas markets is a major milestone, but it does not guarantee supply contracts with foreign...
Zymfentra U.S. Sales Surge 176% as Celltrion’s Remsima Franchise Eyes 1 Trillion Won Annual Revenue

Zymfentra U.S. Sales Surge 176% as Celltrion’s Remsima Franchise Eyes 1 Trillion Won Annual Revenue

Biopharmaceutical company Celltrion announced on Aug. 27 that combined first-half sales of its subcutaneous infliximab products—Remsima SC and...
AbTis Wins U.S. Patent Ruling, Safeguarding Core Rights to AbClick Platform

AbTis Wins U.S. Patent Ruling, Safeguarding Core Rights to AbClick Platform

Antibody-drug conjugate developer AbTis announced on August 14 that it has prevailed in an inter partes review before...
As the U.S. Reconsiders Direct-to-Consumer Drug Ads, What Lessons Should We Learn?

As the U.S. Reconsiders Direct-to-Consumer Drug Ads, What Lessons Should We Learn?

During a yearlong stay in the United States, one of the things that struck me most was how easy it is to come across...
Placebo Outperforms TG-C: Data Errors and Stock Volatility Cloud Kolon TissueGene’s Phase 3 Trial

Placebo Outperforms TG-C: Data Errors and Stock Volatility Cloud Kolon TissueGene’s Phase 3 Trial

Kolon TissueGene’s knee osteoarthritis cell and gene therapy, TG-C, has failed to achieve statistical significance on...
Daewoong Pharmaceutical Cuts Off Hospital Sales After Domestic Nabota Vials Surface in the U.S.

Daewoong Pharmaceutical Cuts Off Hospital Sales After Domestic Nabota Vials Surface in the U.S.

Daewoong Pharmaceutical announced on July 23 that it has severed supply transactions with a domestic medical...
Anchoring the U.S. Supply Chain: GC Green Cross Expands 30-Year Cytiva Partnership to Secure Alyglo Production

Anchoring the U.S. Supply Chain: GC Green Cross Expands 30-Year Cytiva Partnership to Secure Alyglo Production

GC Green Cross has secured priority access to critical manufacturing consumables to stabilize the production of Alyglo,...
MediPost Begins Pivotal U.S. Phase 3 Trial for Regenerative Knee Therapy Cartistem

MediPost Begins Pivotal U.S. Phase 3 Trial for Regenerative Knee Therapy Cartistem

South Korean biotechnology company MediPost has entered full-scale Phase 3 clinical testing in the United States for...
Samsung Biologics Labor Dispute Set for Limited Q2 Impact, but Second-Half Outlook Hinges on Union Deal and U.S. Plant Costs

Samsung Biologics Labor Dispute Set for Limited Q2 Impact, but Second-Half Outlook Hinges on Union Deal and U.S. Plant Costs

With wage and collective bargaining talks between Samsung Biologics and its union still unresolved, analysts expect...
Rznomics Secures U.S. Patent for Alzheimer’s RNA Therapy Candidate RZ-003

Rznomics Secures U.S. Patent for Alzheimer’s RNA Therapy Candidate RZ-003

Rznomics, a biopharmaceutical company specializing in RNA-based gene therapies, announced on the 24th that it has...