Company Product Description Indication Status Date

Beigene Inc., of Beijing

Brukinsa (zanubrutinib)

BTK inhibitor

Mantle cell lymphoma

Approved by FDA for use in adults who have received at least 1 prior therapy


Healios K.K., of Tokyo, and Athersys Inc., of Cleveland

Multistem (HLCM-051)

Cell therapy

Acute respiratory distress syndrome

Japan's Pharmaceutical Affairs and Food Sanitation Council notified companies that the Ministry of Health, Labour and Welfare will grant orphan regenerative medicine designation within the next few weeks


Shionogi & Co. Ltd., of Osaka, Japan

Fetroja (cefiderocol)

Antibacterial drug

Complicated urinary tract infections

FDA approved for use in patients 18 and older with complicated UTIs, including kidney infections caused by susceptible gram-negative microorganisms, who have limited to no alternative treatment options



The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.

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