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BioWorld - Sunday, July 26, 2026
Home » Topics » Regulatory » Policy

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Stem cells
BIX 2025

Opportunity, risks of cell therapy to tackle aging and disease

Oct. 23, 2025
By Marian (YoonJee) Chu
No Comments
Stem cells are a promising therapeutic modality to fight aging and age-related disease, speakers at the Bio-Plus Interphex Korea 2025 said. Progress in cell-based longevity medicine is being made, they added, although safety, ethical and regulatory issues are ongoing challenges.
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Wooden blocks spelling TARIFFS with a U.S. flag on top, placed on a map of Europe

Trade associations push back on Trump Section 232 review

Oct. 21, 2025
By Mark McCarty
The Trump administration’s consideration of a new round of tariffs has prompted two major med-tech trade association to advise the White House to leave medical consumables and medical devices out of any new tariffs, citing concerns about the impact on patient care.
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World with digital overlay

BIX 2025: What ‘radical’ changes in US, China mean for bio sector

Oct. 21, 2025
By Marian (YoonJee) Chu
No Comments
Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
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Capsules and tablets scattered over a world map

MFN drug pricing getting a foothold in the US

Oct. 17, 2025
By Mari Serebrov
No Comments
Caught between the rock and the hard place of most-favored nation (MFN) pricing and the threat of a hefty biopharma sector tariff, drug companies marketing in the U.S. are exploring their options. Several large firms already have committed millions and billions of dollars in investment in new or expanded U.S.-based manufacturing facilities to avoid tariffs on finished drugs.
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World with digital overlay

BIX 2025: What ‘radical’ changes in US, China mean for bio sector

Oct. 15, 2025
By Marian (YoonJee) Chu
No Comments
Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
Read More
Pen and paper

White House ushering in new era of EO governance?

Oct. 15, 2025
By Mari Serebrov
No Comments
While the pace of executive orders (EOs) coming out of the White House has slowed, the Trump administration is still churning them out. As of the end of the third quarter, President Donald Trump had issued 209 EOs. Of those, BioWorld tracked 37 that directly impact drug and device R&D, regulatory burdens, pricing and market competition.
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U.S. Capitol building, Washington D.C.

US federal shutdown bites FDA

Oct. 13, 2025
By Mark McCarty
The budget impasse between Democrats and Republicans on Capitol Hill has implications for a wide range of federal government operations, including at the U.S. FDA, which is absorbing another round of layoffs and cannot accept new premarket filings that require user fee submissions.
Read More
Digital globe illustrating pharma trade, tariffs

Rx tariff a stick and a carrot for US price, onshoring deals

Oct. 13, 2025
By Mari Serebrov
No Comments
Although U.S. President Donald Trump’s Oct. 1 start date for a hefty biopharma sector tariff has come and gone, the threat remains, serving as both a stick and a carrot to get drug companies to come to the table with their best deals.
Read More
Vaccine vial and syringe

Latest ACIP recommendations added to CDC vaccine schedules

Oct. 7, 2025
By Mari Serebrov
No Comments
Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.
Read More
Vaccine vial and syringe

Latest ACIP recommendations added to CDC vaccine schedules

Oct. 6, 2025
By Mari Serebrov
No Comments
Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.
Read More
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