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Home » Topics » Regulatory

Regulatory
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Insightec gains FDA approval for Exablate Neuro use in Parkinson’s

July 8, 2025
By Annette Boyle
Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.
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U.S. Capitol building

Iancu: Patent reform undone by multinationals’ apathy over IP rights

July 8, 2025
By Mark McCarty
Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.
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Medicare puzzle

CMS formally proposes to terminate ESRD choices program

July 8, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services indicated it will act on a previous proposal to terminate the Treatment Choices Model for ESRD at the end of the current calendar year because of a failure of the program to deliver on the promised efficiencies and improvement in outcomes.
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China approves Simcere’s suvemcitug for ovarian cancer

July 8, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance.
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Xray showing lung cancer on tablet

FDA approves Dizal’s sunvozertinib for metastatic non-small-cell lung cancer

July 8, 2025
By Tamra Sami
No Comments
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
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Wuhan Healthgen gets chance at China IPO with SSE market reforms

July 8, 2025
By Marian (YoonJee) Chu
No Comments
Wuhan Healthgen Biotechnology Co. Ltd. gained clearance from the Shanghai Stock Exchange July 1 to list under a recently reinstated IPO growth tier geared towards supporting “unprofitable” biotechnology firms.
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Rare disease illustration

UK industry encourages renewal of rare disease framework

July 8, 2025
By Nuala Moran
No Comments
Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.
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US medical groups challenge Kennedy’s COVID-19 changes

July 7, 2025
By Mari Serebrov
No Comments
Led by the American Academy of Pediatrics, several medical groups went to court July 7 to force Health and Human Services Secretary Robert Kennedy to restore the CDC’s COVID-19 vaccine recommendations for pregnant women and healthy children ages 6 months to 17 years.
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Farawave system

FDA greenlights Boston Sci’s Farapulse for persistent AF

July 7, 2025
By Annette Boyle
Boston Scientific Corp. gained a second U.S. FDA approval for its Farapulse pulsed field ablation catheter, expanding its use into drug-refractory, symptomatic persistent atrial fibrillation (AF) in addition to its existing approval for paroxysmal AF. The expanded indication marks the first of several regulatory approvals the company expects in the coming months.
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australia-flag-country.png

UDI mandates kick in for devices in Australia

July 7, 2025
By Mark McCarty
Australia’s Therapeutic Goods Administration reported June 30 several new regulatory requirements are in effect, including a new mandate regarding the use of unique device identifiers for implanted medical devices.
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