Depending on how long it lasts, the dockworkers strike that hit all 14 ports on the U.S. East Coast and along the Gulf Oct. 1 could literally unload a world of hurt to patients and the ...

Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the ...

The E4 variant of the APO gene, the R47H variant of the TREM2 gene, and female sex are three of the strongest risk factors for the development of Alzheimer’s disease (AD). By combining all three of ...

In the year’s fourth-largest deal, Prime Medicine Inc. will collaborate with Bristol Myers Squibb Co. in a research collaboration and license agreement totaling $3.61 billion. The two companies plan ...

Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted ...

Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and ...

GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in ...

South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events ...

The question of how to define artificial intelligence (AI) for medical product usage was answered by the FDA, which recently offered an AI glossary.

Meeting the deadline the U.S. Health Resources & Services Administration imposed in a Sept. 27 final warning letter, Johnson & Johnson (J&J) notified the agency Sept. 30 that it would not implement ...

Jiangsu Alphamab Biopharmaceuticals Co. Ltd. is out-licensing its anti-HER2 bispecific antibody-drug conjugate, JSKN-003, to JMT-Bio Technology Co. for China rights in a deal worth up to ¥3.08 billion ...

The U.S. FDA has guidances on the books for dental products, but the it unleashed a quartet of guidances – ceramics and cements used in dental procedure – for dental products on the final Friday of ...