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BioWorld - Thursday, January 1, 2026
Home » Topics » North America » U.S.

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Dollar sign dropper and test tube

Trump EO to change the landscape of US grants, awards

Aug. 11, 2025
By Mari Serebrov
No Comments
Billing it as a necessary reform to protect tax dollars from frivolous government spending, redundancy and waste, U.S. President Donald Trump issued a new executive order (EO) requiring his political appointees to sign off on grants and awards from agencies such as the NIH and to monitor those awards over time to ensure they’re being used properly.
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Hernexeos

Boehringer’s Hernexeos wins accelerated nod in lung cancer

Aug. 11, 2025
By Jennifer Boggs
No Comments
Boehringer Ingelheim GmbH’s zongertinib enters the market as the first oral HER2-targeted therapy for patients with non-small-cell lung cancer, following an accelerated approval by the U.S. FDA. Branded Hernexeos, the drug is cleared for use in adults with unresectable disease or whose tumors have HER2 tyrosine kinase domain activating mutations and who have received prior systemic therapy.
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Businessman and IPO virtual screen

Heartflow raises $317M, pops 66% at market open

Aug. 8, 2025
By Annette Boyle
Heartflow Inc. upped the price of shares in its IPO for a second time to $19 on Aug. 7 before opening on the Nasdaq as “HTFL” at $28 and climbing to $31.50 in early trading. The IPO raked in $316.7 million for the 16.67 million shares sold, giving the cardiology company a valuation of $2.27 billion.
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Boston Scientific - Watchman FLX

FDA says Watchman access alert remedied by review of IFU

Aug. 8, 2025
By Mark McCarty
The U.S. FDA posted an Aug. 6 early alert regarding the use of the Watchman left atrial appendage device by Boston Scientific Corp., citing instances in which the device’s delivery system is associated with events of embolism.
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Instylla Inc Embrace

Instylla wins FDA PMA for Embrace hydrogel embolic system

Aug. 8, 2025
By Holland Johnson
Just two days after reporting the appointment of a new CEO, Instylla Inc. said it received a premarket approval from the U.S. FDA for its flagship product Embrace hydrogel embolic system. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries.
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Gavel and pill blister packs

US government chalks up more court wins on Rx negotiations

Aug. 8, 2025
By Mari Serebrov
No Comments
Drug companies and organizations challenging the Medicare drug negotiations have yet to convince a U.S. court that the process, mandated by the 2022 Inflation Reduction Act, violates the Constitution. The most recent decisions came this week when the U.S. Court of Appeals for the Second Circuit ruled Aug. 7 against Boehringer Ingelheim GmbH and the Sixth Circuit ruled Aug. 6 against a challenge filed by the Dayton, Ohio, Chamber of Commerce, the U.S. Chamber, and the Ohio and Michigan Chambers.
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Close up dermatitis on the skin

OX40 AD-ding to derm pipelines of players big and small

Aug. 8, 2025
By Randy Osborne
No Comments
Among the strong points of Nektar Therapeutics Inc.’s atopic dermatitis (AD) prospect, rezpegaldesleukin (rezpeg), an IL-2 pathway agonist and regulatory T-cell proliferator, is the drug’s faster onset of action – a feature that experts say may help differentiate the compound from competitors in the OX40 space.
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Gregory Verdine, founder and CEO, Dovetree
Drug design, drug delivery & technologies

Xtalpi finalizes $6B AI drug discovery deal with Dovetree

Aug. 8, 2025
By Marian (YoonJee) Chu
No Comments
Quantumpharm Inc., known as Xtalpi Inc., announced receiving $51 million up front from a potential $5.99 billion deal with Dovetree LLC on Aug. 6. The collaboration, first inked through a letter of intent between the two parties on June 23, will combine Shenzhen, China-based Xtalpi’s AI-based and robotics-driven discovery platform with Dovetree’s “biological insights.” The goal will be to select and validate potential first-in-class candidates for Dovetree across five areas of oncology, immunology and inflammatory diseases, neurological disorders and metabolic dysregulation.
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Green, blue, gray dollar signs

Histosonics sells majority stake for $2.25B

Aug. 7, 2025
By Annette Boyle
A management-led syndicate of prominent investors acquired a majority stake in Histosonics Inc. that values the company at approximately $2.25 billion. The funding will support expansion of the Edison Histotripsy system and therapy platform into new clinical indications and markets. Edison uses non-invasive focused ultrasound energy to destroy tumors.
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Gavel and FTC logo

US FTC moves to thwart Edwards’ acquisition of Jenavalve

Aug. 7, 2025
By Mark McCarty
The U.S. Federal Trade Commission (FTC) reported Aug. 6 that it will try to block Edwards Lifesciences Corp.’s proposed acquisition of Jenavalve because Edwards’ acquisition of both Jenavalve Technology Inc. and JC Medical would eliminate competition in the TAVR space for aortic regurgitation.
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