Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Cormedix.
Sirpant Immunotherapeutics Inc.’s lead product candidate, Sirpant-M (SI-101), has been awarded U.S. orphan drug designation for the treatment of T-cell lymphoma.
Epic Bio (Epicrispr Biotechnologies Inc.) has announced that EPI-321 has been awarded U.S. orphan drug designation for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
The FDA has cleared Versameb AG’s IND application for VMB-100, a potency-enhanced mRNA encoding human insulin-like growth factor-1 (IGF-1), for the treatment of stress urinary incontinence.
After Cormedix Inc. navigated manufacturing issues that slowed the process, the U.S. FDA approved the antibacterial and antifungal solution Defencath to reduce catheter-related bloodstream infections adults with kidney failure.
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.
The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee has a lot to discuss Nov. 17, but only one voting question: Does the evidence demonstrate that Merck & Co. Inc.’s gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough?
Lunit Inc. is the latest South Korean firm to gain the U.S. FDA’s 510(k) clearance for Lunit Insight DBT, its artificial intelligence (AI)-powered breast cancer diagnostic tool that analyzes digital breast tomosynthesis (DBT) images, boosting its efforts to enter the U.S. market. The company also reported that it secured $150 million in a public offering.
The artificial intelligence (AI) space doesn’t exactly lack for stakeholders, but the roster of stakeholders in the U.S. is poised to grow by hundreds of millions, according to Laura Adams, senior advisor at the U.S. National Academy of Medicine.
Solid Biosciences Inc. has received FDA clearance of its IND application for SGT-003, the company’s next-generation gene therapy candidate for Duchenne muscular dystrophy (DMD). The planned first-in-human phase I/II trial will enroll pediatric patients with DMD to receive SGT-003 as a one-time intravenous infusion.
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