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Home » Topics » Regulatory

Regulatory
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Doctor examining child in wheelchair
Neurology/psychiatric

Entrada’s ENTR-601-45 gains clearance in UK to enter clinic for Duchenne muscular dystrophy

March 24, 2025
Entrada Therapeutics Inc. has received authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and research ethics committee to initiate a phase I/II study of ENTR-601-45 for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 45 skipping.
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US FDA deals second blow to Hengrui-HLB’s liver cancer drug combo

March 21, 2025
By Marian (YoonJee) Chu
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
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Green approved stamp
Biopharma regulatory actions and approvals February 2025

Global drug approvals hit 47 in February, surpassing 2024 monthly average

March 21, 2025
By Amanda Lanier
The U.S. FDA approved 16 drugs in February, up from 12 in January but still falling short of the 2024 monthly average of 19 approvals. Just two of those were new molecular entities (NMEs), continuing a slower pace compared to the year’s average of slightly more than four NMEs per month.
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Health professional touching screen, digital/medical icons

AI legislation advances in US states as Washington dithers

March 21, 2025
By Mark McCarty
Several American states are forging into a legislative vacuum where regulation of AI is concerned as Congress continues to delay action. Adoption of AI regulations on a state level increases the risk of a fragmented regulatory landscape, as already exists in U.S. privacy law, further complicating the path forward for med-tech companies deploying AI algorithms.
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FDA approved icons and medical professional

Have kit, will travel further: Telix PET-imaging agent approved by FDA

March 21, 2025
By Lee Landenberger
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.
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Art concept for tumor
Immuno-oncology

CSPC Pharmaceutical’s SYS-6040 cleared to enter clinic in China for advanced solid tumors

March 21, 2025
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYS-6040 for advanced solid tumors.
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Evoque valve sizes

US Medicare’s TTVR aligns closely with draft, T-TEER devices en route

March 20, 2025
By Mark McCarty
The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.
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Prescription pad

Legislation would authorize AI to write prescriptions

March 19, 2025
By Mark McCarty
The unrelenting pressure on medical practice in the U.S. has sparked some innovations, but a legislative innovation is now in the works that would fundamentally shift how at least some drugs are prescribed. The Healthy Technology Act of 2025 (H.R. 238) would allow AI and machine learning algorithms to write prescriptions for pharmaceuticals, although the lack of co-sponsors for H.R. 238 suggests that this bill is not ready for prime time just yet.
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Website of The Federal Trade Commission

Trump halves the FTC, firing Democratic commissioners

March 19, 2025
By Mari Serebrov
The politicization of the U.S. FTC continued March 18 with President Donald Trump firing the two remaining Democratic commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya. The action leaves what’s supposed to be a five-member bipartisan panel with just two members, both of whom are Republicans. The commission already was down one member, as former Chair Lina Khan’s term expired last year and Trump’s appointee, Mark Meador, is awaiting Senate confirmation with a vote expected yet this month.
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Product recall concept image

Latest device recalls include Medtronic embolization devices

March 19, 2025
By Mark McCarty
The U.S. FDA has posted several class I recalls in recent days, including a removal of one model of the Medtronic Vascular’s Pipeline Vantage embolization device due to insufficient apposition to the vessel wall.
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