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Home » Topics » Regulatory

Regulatory
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VIisumax 800 with Smile-pro software

Carl Zeiss Meditec receives FDA approval for latest femtosecond laser

Jan. 24, 2024
By Shani Alexander
Carl Zeiss Meditec AG recently received U.S. FDA clearance for the latest generation of its femtosecond laser, the Visumax 800, with its Smile pro software, for surgically treating nearsightedness, with or without astigmatism.
Read More
EU flags

European Commission provides another delay in IVDR compliance deadlines

Jan. 24, 2024
By Mark McCarty
The European Commission (EC) has proposed another delay in the compliance deadlines for the In Vitro Diagnostic Regulation (IVDR) that eases the existing timelines by roughly two and a half years. The news was welcomed by Medtech Europe, which nonetheless pressed the EC and others to patch up some of the issues that led to the new extensions in the first place.
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Immuno-oncology

Harbour’s bispecific antibody HBM-9027 cleared to enter clinic in US for solid tumors

Jan. 24, 2024
Harbour Biomed Ltd. has obtained FDA clearance of its IND application to initiate a first-in-human...
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Neurology/Psychiatric

Vanda receives IND clearance for ASO for Charcot-Marie-Tooth disease type 2S

Jan. 24, 2024
Vanda Pharmaceuticals Inc. has announced FDA approval of its IND application to evaluate VCA...
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Neurology/Psychiatric

Juvena’s JUV-161 awarded US orphan drug designation for myotonic dystrophy type 1

Jan. 24, 2024
The FDA has awarded orphan drug designation to Juvena Therapeutics Inc.’s JUV-161, an...
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Red wooden approved stamp

NMPA approves China’s second homegrown SGLT2 inhibitor janagliflozin

Jan. 23, 2024
By Marian (YoonJee) Chu
Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the second China-made SGLT2 inhibitor after Jiangsu Hengrui Medicine Co. Ltd.’s henagliflozin (SHR-3824), which was launched domestically in May 2022.
Read More
Doctor with stethoscope listening to heart of girl

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation

Jan. 23, 2024
By Tamra Sami
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
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FDA issues complete response letter to Satsuma for migraine NDA over CMC issues

Jan. 23, 2024
By Tamra Sami
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101.
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Laptop displaying FDA logo

US FDA says reorganization a tough slog in tight budgetary environment

Jan. 23, 2024
By Mark McCarty
The U.S. FDA is undergoing a significant overhaul of operations which is designed in part to make the agency’s Office of Regulatory Affairs (ORA) more efficient and less obtrusive to product centers, such as the Center for Devices and Radiological Health.
Read More
b-rayZ software solution

B-rayz receives CE mark for AI tool for breast cancer detection

Jan. 23, 2024
By Shani Alexander
B-rayz AG received CE mark for its Data Adaptive Neural Artificial Intelligence (DANAI) technology that helps clinicians with breast cancer detection. The company hopes that DANAI, which introduces a custom AI-based framework that can adapt to clinicians needs and grow smarter in the process, will revolutionize the diagnostic landscape for breast imaging and transform the lives of millions of women.
Read More
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