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BioWorld - Saturday, May 30, 2026
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China and U.S. flags

Life sciences ‘sweet’ opportunity in US-China talks

May 13, 2026
By Mari Serebrov
No Comments
Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14.
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Magnifying glass on wooden table

Multiple appearances on Priority Watch List leading to action?

May 12, 2026
By Mari Serebrov
No Comments
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
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Hantavirus cells

APAC monitors hantavirus as Singapore isolates 2 from cruise ship

May 12, 2026
By Marian (YoonJee) Chu
No Comments
Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far.
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Martin Makary, former FDA-commissioner

Makary out at the FDA

May 12, 2026
By Mari Serebrov
No Comments
U.S. President Donald Trump ended days of rumors and speculation when he confirmed May 12 that Marty Makary is resigning as FDA commissioner. Speaking with reporters before heading off to China for a two-day summit, Trump wouldn’t comment on whether he or someone else asked Makary to step down. However, while calling Makary a “wonderful man” and a “great guy, who’s a friend of mine,” the president acknowledged that “he was having some difficulty” at the FDA.
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US map with arrows pointing inward

Commerce gives Rx companies 30 days to submit US onshoring plans

May 12, 2026
By Mari Serebrov
No Comments
Companies seeking a break in the soon-to-be-implemented U.S. Section 232 biopharma tariffs have 30 days to apply for a company-specific onshoring agreement with the Department of Commerce, according to the procedures the department laid out in a notice to be published in the May 13 Federal Register.
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Beta cells
Endocrine/metabolic

Fractyl Health’s RJVA-001 cleared to enter clinic in Netherlands

May 12, 2026
No Comments
Fractyl Health Inc. has received clinical trial application authorization in the Netherlands to initiate a first-in-human phase I/II study of RJVA-001, the first clinical candidate from the company’s Rejuva Smart GLP-1 gene therapy platform.
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Pregnancy

FDA pregnancy safety guidance evolves with the science

May 11, 2026
No Comments
Seven years, almost to the day, after releasing a draft guidance on post-approval pregnancy safety studies, the U.S. FDA is now finalizing it – albeit with a few changes.
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Glean abdominal sensor

Bright Uro secures FDA approval for abdominal sensor

May 11, 2026
By Shani Alexander
No Comments
Bright Uro Inc. secured U.S. FDA 510(k) clearance for the Glean abdominal sensor, which expands the capabilities of its Glean urodynamics system to enable multichannel urodynamic studies. The new sensor will allow clinicians to perform multichannel urodynamics, capturing both abdominal and detrusor pressures without the need for catheters, supporting treatment decision-making for patients with lower urinary tract dysfunction and other urological conditions.
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Hands holding holographic intestine
Gastrointestinal

Mabwell’s 9MW5211 gains IND clearance for IBD

May 11, 2026
No Comments
Mabwell (Shanghai) Bioscience Co. Ltd. has obtained IND clearance from the FDA for 9MW5211 for the treatment of inflammatory bowel disease (IBD).
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Hantavirus cells

APAC monitors hantavirus as Singapore isolates 2 from cruise ship

May 8, 2026
By Marian (YoonJee) Chu
No Comments
Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far.
Read More
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