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Regulatory actions for May 25, 2023

May 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kane Biotech.
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Regulatory actions for May 24, 2023

May 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Zoll Medical.
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endoangel.jpg

Endoangel’s AI-based diagnosis system for endoscopy is approved in China

May 24, 2023
By Doris Yu
Wuhan Endoangel Medical Technology Co. Ltd.’s artificial intelligence (AI)-assisted real-time quality control and auxiliary diagnosis system for lower gastrointestinal endoscopy has been approved by China’s NMPA.
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Sequana---Alfapump,-Cathether,-charger.jpg

Sequana considers listing in the US as it looks for growth for Alfapump

May 24, 2023
By Shani Alexander
Sequana Medical NV is considering listing in the U.S. as it builds towards the commercialization of its Alfapump, CEO Ian Crosbie told BioWorld in an interview. The company has received a U.S. FDA breakthrough device designation for Alfapump, which treats recurrent or refractory ascites due to liver cirrhosis, and it completed a pivotal study in 2022. The company intends to file the data with the FDA by the end of this year, with the hope of getting premarket approval before the end of 2024.
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US CMS flexes muscle in proposing Medicaid Rx pricing tools

May 24, 2023
By Mari Serebrov
The U.S. Centers for Medicare & Medicaid Services (CMS) is flexing its new authority in a proposed rule intended to clamp down on drug prices by providing more transparency in the Medicaid program.
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India ramps up testing requirements after contaminated cough syrup exports

May 24, 2023
By T.V. Padma
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
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Regulatory actions for May 24, 2023

May 24, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Antengene, Blueprint, Boehringer Ingelheim, Cumberland, Indivior, Junshi, Pharmabcine, Pharmessentia, Regenxbio, Rocket, Vega, Y-mabs.
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Xacduro

Entasis’ bacterial infection drug receives FDA approval

May 24, 2023
By Lee Landenberger
A week ahead of its May 29 PDUFA date, the U.S. FDA has approved Xacduro (sulbactam for injection; durlobactam for injection) for treating one of the toughest and most deadly infections, carbapenem-resistant Acinetobacter baumannii, in adults.
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Regulatory actions for May 23, 2023

May 23, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artivion.
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Ayvakit product image

Following the Blueprint for expansion-ISM: FDA says yes to widened label in rare mast-cell disease

May 23, 2023
By Randy Osborne
Blueprint Medicines Corp. scored a broader label from the U.S. FDA for Ayvakit (avapritinib), which became the first approved therapy to treat adults with indolent systemic mastocytosis (ISM).
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