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BioWorld - Tuesday, June 16, 2026
Home » Topics » Regulatory

Regulatory
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Jyong’s $20M US IPO to help refile NDA of urological botanic drug

June 24, 2025
By Marian (YoonJee) Chu
No Comments
Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price.
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FDA icons

FDA scrutinizing trials sending US patient cells to China

June 24, 2025
By Mari Serebrov
No Comments
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
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No postponement likely for ACIP meeting

June 24, 2025
By Mari Serebrov
No Comments
Barely a day before the eight new members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are supposed to hold their first meeting, Sen. Bill Cassidy, R-La., called for the June 25 meeting to be postponed.
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HHS Secretary Robert Kennedy

HHS budget hearing mashup of the worst and the best

June 24, 2025
By Mari Serebrov
No Comments
“I expressed deep concerns with your nomination, Secretary Kennedy, and somehow, unfortunately, you have exceeded my expectations in the worst possible ways,” U.S. Rep. Frank Pallone, D-N.J., told Health and Human Services (HHS) Secretary Robert Kennedy during a June 24 House subcommittee hearing.
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Medicare puzzle

MedPAC sounds alarm over Medicare physician pay rates

June 23, 2025
By Mark McCarty
The Medicare Payment Advisory Commission advised Congress that inflation is taking a bite out of physician pay and Medicare payments may have to increase in order to preserve patient access to care.
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Art concept for gene therapy research

Deepecho secures FDA clearance for fetal imaging platform

June 23, 2025
By Shani Alexander
Deepecho Inc. received the U.S. FDA’s nod for its AI-based platform that assesses fetal biometry and amniotic fluid volume to improve the efficiency and precision of fetal ultrasound diagnostics.
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MHRA logo

UK’s MHRA opens second round in AI airlock program

June 23, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency opened a second round in its AI airlock program although this round, like the first round, will be limited to four applicants.
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FDA Approved stamp with blister pack
Biopharma regulatory actions and approvals May 2025

Novavax jumps 15% on COVID shot nod, among 14 FDA approvals in May

June 23, 2025
By Amanda Lanier
No Comments
The U.S. FDA approved 14 drugs in May, a decline from 20 in April and 22 in March. That brings the year-to-date total for 2025 to 84 approvals, the second highest on record for this period, just behind the 89 approvals recorded in the first five months of 2024.
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Syringe in spotlight

Under new management, ACIP faces intense scrutiny

June 23, 2025
By Mari Serebrov
No Comments
The June 25-26 meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) will be anything but business as usual. In wiping the slate clean just two weeks before the panel was to meet, Health and Human Services Secretary Robert Kennedy made sure of that.
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3D illustration showing presence of tumor inside prostate gland
Cancer

Archeus gains IND clearance for ART-101 in prostate cancer

June 23, 2025
No Comments
Archeus Technologies Inc. has obtained IND clearance from the FDA for ART-101, a novel receptor-based targeting small molecule for the imaging and treatment of prostate cancer.
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