Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
Putting into jeopardy what was on track to be the first approved therapy in Europe for geographic atrophy (GA), an advanced form of age-related macular degeneration that causes blindness, Apellis Pharmaceuticals Inc. learned of a negative trend vote by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on its MAA for intravitreal pegcetacoplan.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonesupport, Corista, Glaukos, Medtronic.
The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far.
Iecure Inc. has received clearance from the Australian Therapeutic Goods Administration (TGA) of the company’s clinical trial notification (CTN) for ECUR-506 (formerly GTP-506), an investigational therapy in development for the treatment of ornithine transcarbamylase (OTC) deficiency in pediatric (or neonatal) patients.
The U.S. FDA is assembling a new advisory committee specifically focused on treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee, or GeMDAC, will be tasked with providing agency reviewers independent expert recommendations regarding regulatory applications as well as advice on scientific and policy issues.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ion Beam, CMI, Life Molecular, Rapid Medical, Xpan.
The U.K. National Institute for Health and Care Excellence is not utterly opposed to the use of mechanical thrombectomy as a treatment for pulmonary embolism, but the agency believes that the outcomes data for high-risk patients are lacking.
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
Immuneering Corp. has obtained FDA clearance of its IND application for IMM-6-415, an oral, twice-daily small molecule in development for the treatment of advanced RAF or RAS mutant solid tumors.
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