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Home » Topics » North America » U.S.

U.S.
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Person holding Carmat's bio-prosthetic artificial heart

Hearts break as Carmat faces insolvency

June 23, 2025
By Annette Boyle
Bioprosthetic heart maker Carmat SA shares collapsed on June 23, reaching €0.28 on the Paris Stock Exchange after the company announced it would run out of cash by the end of the month without immediate financial support.
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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.
Read More
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.
Read More
Businessman and IPO virtual screen

Caris settles IPO at $21, trading starts at $28

June 20, 2025
By Annette Boyle
Despite raising the price of its IPO twice, Caris Life Sciences Inc. left money on the table with a 33% increase in price as soon as trading commenced on the Nasdaq, though no one is squawking about raising nearly $500 million. The cancer diagnostics company initially priced its IPO at $16 to $18, then raised it to $19 to $20, before closing on a price of $21 per share. As management rang the bell for the start of trade on June 18, shares began trading at $28.
Read More
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.
Read More
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
Neuromark system

Rising demand spurs Neurent to open new Neuromark facility

June 18, 2025
By Shani Alexander
Amid rising demand for its Neuromark system, Neurent Medical Ltd. opened a new manufacturing facility in Ireland, which will serve as the central hub for the production of the device which treats chronic rhinitis.
Read More
JAMA OpEd

Too much at stake for dismissed ACIP members to go quietly

June 18, 2025
By Mari Serebrov
No Comments
The 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices are not going gently into the night. Instead, they’re raging against what could be the dying of the light.
Read More

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

June 18, 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.
Read More

Avata, Oceanus partner on cannabidiol for epilepsy, schizophrenia

June 18, 2025
By Tamra Sami
No Comments
Avata Biosciences Holdings Ltd. and Oceanus Bio Inc. have inked a drug discovery and development deal worth up to $95 million for two of Avata’s cannabidiol compounds.
Read More
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