Rigel Pharmaceuticals Inc.’s ahead-of-deadline approval from the U.S. FDA of Rezlidhia (olutasidenib) twice-daily capsules for adults with relapsed/refractory (r/r) acute myeloid leukemia (AML) came as a surprise to the company, but followed encouraging interactions, “including a very positive midcycle review meeting,” said CEO Raul Rodriguez, adding that the firm will “redouble our efforts to make sure we're able to convey the information supporting this product” to the marketplace. Regulators had assigned the compound a Feb. 15, 2023, PDUFA date.
Lepu Medical Technology (Beijing) Co. Ltd. has been given the green light from China’s NMPA for its disposable micro-guidewire. Beijing, China-based Lepu Medical confirmed to BioWorld that this micro-guidewire was approved for fractional flow reserve (FFR) measurements in adult patients with coronary artery lesions during coronary angiography and interventional procedures.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Aurinia, Bluejay, Citius, Eli Lilly, Ferring, Innoviva, Nuvectis, Oncolytics, Opus Genetics, Orchard, Pyxis, Scynexis, Sparingvision.
The U.S. Federal Trade Commission (FTC) has moved decisively in the area of mergers and acquisitions recently, but the agency also has a footprint in the enforcement space for health data disclosure. The FTC’s Ronnie Solomon said in a Dec. 1 public meeting that the agency will begin “thinking outside the box about what health information is in the 21st Century,” adding that the FTC is eyeing a more stringent enforcement regime regarding personal health data disclosures in the coming new year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Enovis, Hemosonics, Wise.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ananda, Aum, First Wave, Lobe, Nova Mentis, Regeneron, Sensorion, Transcode, Vistagen.
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product.
A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Egg Medical, Electromed, Pulmonx, Surgibox, Treace Medical Concepts.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Ascletis, Buchang, Capstone, Caribou, Genentech, Gilead, Kala, Novavax, Remd, Sofie.
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