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Home » Topics » Regulatory » FDA

FDA
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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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Robert Paris, vice president, Moderna
Global Vaccine Forum 2025

Moderna expands mRNA tech to latent viruses, cancer, rare disease

June 24, 2025
By Marian (YoonJee) Chu
No Comments
Post pandemic, Moderna Inc. is broadening the applications of mRNA technology to cancer, rare diseases, latent viruses and respiratory viruses, “taking advantage” of the revenue generated by Spikevax (elasomeran), its mRNA-based vaccine for COVID-19.
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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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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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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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BIO2025: John Crowley and Martin Makary
BIO 2025

Makary lays out FDA’s path, launches pilot review program

June 20, 2025
By Karen Carey
No Comments
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
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FDA icons

FDA scrutinizing trials sending US patient cells to China

June 20, 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.
Read More

CBER shakeup points to further FDA realignment

June 20, 2025
By Lee Landenberger
No Comments
The realignment within the U.S. FDA continued with reports of the removal of two high level executives. When asked by BioWorld if the Center for Biologics Evaluation and Research’s (CBER) Office of Therapeutic Products director and deputy director had been forced out and if so, why, an HHS spokesperson responded on background with a single sentence: “Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.”
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3d rendering of bispecific antibodies
Cardiovascular

Diagonal Therapeutics’ DIAG-723 designated orphan drug for hereditary hemorrhagic telangiectasia

June 19, 2025
No Comments
Diagonal Therapeutics Inc.’s DIAG-723 has been awarded orphan drug designation by the FDA for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the EMA has provided a positive opinion for orphan drug designation, confirming that DIAG-723 meets the criteria for designation as an orphan drug in the E.U.
Read More
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