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Home » Topics » Regulatory

Regulatory
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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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Court order holds HHS to the law when removing online data

July 7, 2025
By Mari Serebrov
No Comments
Finding they were “arbitrary and capricious” under the Administrative Procedures Act, the District Court for the District of Columbia vacated a White House Office of Personnel Management memo and a subsequent Department of Health and Human Services’ guidance intended to implement President Donald Trump’s Day 1 executive order pertaining to gender ideology.
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Ekterly pill and packaging

Missed PDUFA history as Kalvista wins FDA approval for HAE

July 7, 2025
By Lee Landenberger
No Comments
After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein inhibitor now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development. Ekterly is the first orally-delivered on-demand treatment, as all others in the U.S. are intravenously or subcutaneously administered.
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Wuhan Healthgen gets chance at China IPO with SSE market reforms

July 7, 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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EU flag and microscope

EU unveils new ‘Choose Europe for life sciences’ strategy

July 7, 2025
By Nuala Moran
No Comments
The EU is to harness the “silver economy” of its aging population to help drive innovation and growth as part of a new strategy to make Europe “the most attractive place in the world for life sciences by 2030.”
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China approves Simcere’s suvemcitug for ovarian cancer

July 7, 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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3D rendering of an antibody drug conjugate
Immuno-oncology

Innocare’s ICP-B794 gains IND clearance in China

July 4, 2025
No Comments
Innocare Pharma Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of the B7-H3 targeted antibody-drug conjugate.
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Multiple myeloma illustration
Immuno-oncology

Brightpath’s BP-2202 designated orphan drug for multiple myeloma

July 4, 2025
No Comments
Brightpath Biotherapeutics Co. Ltd.’s iPS cell-derived BCMA CAR-natural killer T cell therapy candidate has been awarded orphan drug designation by the FDA for the treatment of multiple myeloma.
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