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BioWorld - Tuesday, July 28, 2026
Home » Topics » Regulatory, BioWorld Asia

Regulatory, BioWorld Asia
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More approvals by FDA: Rare disease, oncology and HKEX remain the focus

Sep. 25, 2019
By Elise Mak
SUZHOU, China – The global biotech market continues to look promising and Chinese companies are taking notice as they lay the foundation for new advances.
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S. Korea must ease regs, fast-track tech solutions to spur cell, gene therapy R&D

Sep. 4, 2019
By Jihyun Kim
SEOUL – South Korea's investors have become very interested in the global cell and gene therapy market. Licensing and M&A deals in the field have been active – a good sign for Korean biopharma firms eager to tap in.
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Daiichi's Turalio go-ahead casts CSF1R into spotlight; 'headroom' for Deciphera

Aug. 7, 2019
By Randy Osborne
Deciphera Pharmaceuticals Inc. CEO Steven Hoerter told BioWorld Asia the FDA approval of Turalio (pexidartinib) from Daiichi Sankyo Co. Ltd. last week "leaves a lot of headroom for efficacy," given the response rate of about 40%. "One of the most significant concerns that the FDA had was hepatotoxicity, which is an off-target effect," he added, so the approval came with "some fairly onerous monitoring requirements." 
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FDA makes Daiichi's Turalio first approved therapy for rare cancer

Aug. 7, 2019
By Randy Osborne
Tokyo-based Daiichi Sankyo Co. Ltd.'s Turalio (pexidartinib) won FDA clearance for adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.
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