Electromedical Products International Inc. (EPI) Alpha-Stim AID technology is finally being made available by the NHS in the U.K. to treat patients with anxiety some two years after the National Institute for Health and Care Excellence (NICE) said there was not enough good-quality evidence to support the case for routine adoption.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Candela, Magstim.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Astellas, Curis, Kazia, Kyverna, Merus, Novavax, OSE, Sihuan.
The black box warning appended to the label of Alzheimer’s disease (AD) drug Leqembi (lecanemab) took some on Wall Street mildly aback but failed to surprise others, as analysts mulled what the full approval, granted July 6 by the U.S. FDA, might mean for other developers in the space.
The Association for Accessible Medicines fired off a constitutional challenge in U.S. federal court July 5 to provisions included in Minnesota’s new budget law that would restrict price increases for generic and off-patent drugs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bellaseno, Biotronik, Genesis Medtech, Inovedis, Livsmed, Medrhythms.
The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Amneal, Ayala, Biocardia, C4, Clarity, Impact, Incyte, Infant, Jacobio, Moderna, Poseida, Rarestone, Taiho, Tiumbio, Vertex.
South Korean pharmaceutical giant Yuhan Corp. gained Korea’s MFDS approval to expand indications for its potent oral third-generation tyrosine kinase inhibitor Leclaza (lazertinib) as a first-line treatment for EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC).
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