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BioWorld - Tuesday, June 2, 2026
Home » Topics » Regulatory

Regulatory
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Eli Lilly commits $500M to boost South Korea’s biomedical sector

March 9, 2026
By Marian (YoonJee) Chu
No Comments
Eli Lilly and Co. will invest $500 million to support South Korea’s biopharmaceutical industry over the next five years, following high-level talks March 9 between Prime Minister Kim Min-seok and Lilly Executive Vice President Patrik Jonsson.
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Taiwan President Lai Ching-te presides over the seventh meeting of the Healthy Taiwan Promotion Committee.

Taiwan to invest $752M in biopharma security over four years

March 9, 2026
By Marian (YoonJee) Chu
No Comments
Taiwan plans to invest NT$24 billion (US$752 million) over four years to bolster national biosecurity, expand domestic pharmaceutical production and safeguard against global supply chain volatility.
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Rare disease illustration

Forecast brighter for Uniqure with Prasad’s departure?

March 9, 2026
By Mari Serebrov
No Comments
The regulatory clouds that have been darkening the U.S. FDA landscape of late for Uniqure NV’s gene therapy AMT-130 in Huntington’s disease may be parting a bit with the announced departure of Vinay Prasad as director of the agency’s CBER at the end of April.
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Green and red bispecific antibodies
Dermatologic

China’s NMPA clears HBM-7575 to enter clinic in atopic dermatitis

March 9, 2026
No Comments
Harbour Biomed Ltd. and Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. have announced IND approval by China’s National Medical Products Administration (NMPA) for HBM-7575 (SKB-575) for the treatment of atopic dermatitis.
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Claire, an AI-powered imaging device

Perimeter gets FDA nod for imaging device for breast cancer surgery

March 6, 2026
By Shani Alexander
No Comments
Perimeter Medical Imaging AI Inc. secured FDA premarket approval for Claire, its AI-powered imaging device which detects difficult-to-see cancer during breast-conserving surgery. Claire combines AI with wide-field optical coherence tomography to provide surgeons with high-resolution, real-time views of excised tumor margins, to reduce the need for re-operations.
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Induced pluripotent stem cells

Japan approves first iPSC therapy for Parkinson’s disease

March 6, 2026
By Tamra Sami
No Comments
Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.
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Korea ARPA-H roundtable

Korean ARPA-H to invest ₩162B in nine projects in 2026

March 6, 2026
By Marian (YoonJee) Chu
No Comments
The K-health MIRAE Initiative, also known as Korean ARPA-H, announced plans to allocate about ₩162 billion (US$110 million) in nine new projects over the next five years, with a focus on strengthening national health security.
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3D illustration of RNA
Endocrine/metabolic

China’s NMPA clears China Medical System’s CMS-D008 for clinic

March 6, 2026
No Comments
China Medical System Holdings Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for CMS-D008 injection for overweight or obese individuals.
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3D Rendering of tumor microenvironment
Immuno-oncology

FDA clears IND for epigenetic immunoactivator

March 6, 2026
No Comments
Great Novel Therapeutics Biotech & Medicals Corp.’s epigenetic immunoactivator, GNTbm-38, has received IND clearance from the FDA, enabling initiation of a phase I trial in the U.S. 
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Lung cancer driven by the Kras oncogene shown in purple
Cancer

Kestrel’s KST-6051 gains IND clearance for KRAS-driven cancers

March 6, 2026
No Comments
Kestrel Therapeutics Inc. has obtained IND approval from the FDA for KST-6051, an oral, small-molecule pan-KRAS inhibitor being developed for the treatment of KRAS-driven cancers.
Read More
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