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Home » Topics » North America » U.S.

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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.
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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.
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Scientist, microscope and dropper

US universities developing alternative to cover indirect costs

June 18, 2025
By Mari Serebrov
No Comments
After years of conversations surrounding indirect research costs, academic groups are now under the gun to quickly come up with an alternative to the NIH’s proposed 15% across-the-board cap on indirect costs and the decades-old university-by-university negotiated rate that can exceed a 50% add-on to a grant.
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Cheering Immuneering, Street hopes high in pancreatic

June 18, 2025
By Randy Osborne
No Comments
Immuneering Corp.’s phase IIa data from an ongoing trial in pancreatic cancer disclosed June 17 impressed Wall Street and brought renewed attention to the perennially difficult indication, at which drug developers continue to fling themselves with varied mechanisms.
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Stock chart, upward arrow

An early stage 85% remissions rate in AML drives Aptevo’s stock surge

June 18, 2025
By Lee Landenberger
No Comments
An 85% remissions rate was found in updated results from Aptevo Therapeutics Inc.’s ongoing phase Ib/II Ranier study of mipletamig in one of the toughest blood cancers to treat.
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BIO2025: John Crowley and Martin Makary

BIO 2025: Makary lays out FDA’s path, launches pilot review program

June 18, 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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Andembry

New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

June 18, 2025
By Karen Carey and Tamra Sami
No Comments
Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
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Blood clot blocking a blood vessel

Inquis, Penumbra advance thrombectomy treatments

June 17, 2025
By Annette Boyle
Two med-tech companies focused on pulmonary embolism overcame their own blockages to commercialization this week. Inquis Medical Inc.’s Aventus thrombectomy system received U.S. FDA clearance for use in pulmonary embolism, an expanded indication, while Penumbra Inc. completed enrollment in the STORM-PE clinical trial of its Lightning Flash device.
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Lungs and bronchiole

CMS agrees to cover at-home ventilation for chronic respiratory failure

June 17, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services finalized a coverage policy for at-home ventilation for patients with chronic respiratory failure. The amended policy also establishes a series of criteria for coverage of ventilation for chronic obstructive pulmonary disease.
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De novo key on keyboard

FDA releases another batch of regs for de novo decisions

June 17, 2025
By Mark McCarty
It appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm.
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