Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ashvattha, Basilea, Bird Rock, Cardiff, Cerecor, Chiesi, Immodulon, Macrogenics, Moleculin, Orpheris, Phasebio, Protalix, Roche, Theraly.
The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.
Intravenous artesunate, the international standard of care to treat severe malaria, has finally won full FDA approval for the condition, which affects about 300 of the approximately 2,000 people diagnosed with malaria in the U.S. each year.
As the FDA continues to shift its limited resources to the development and review of COVID-19 therapies and vaccines, other drugs in the pipeline may be delayed. In a question-and-answer guidance released late Tuesday, the agency acknowledged that, going forward, it may not be able to sustain its current performance level in meeting all its goal dates for new drugs and biologics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amivas, Anivive, Astellas, Azitra, Beyond Air, BMS, Diffusion, Fresenius Kabi, GSK, Immunitybio, Intelgenx, Microbion, Protara, Radius, Regenerx, Regeneron, Relmada, Sanofi, Sorrento.
Nearly four years after differences between U.S. and Russian clinical results derailed an NDA for its pregnancy prevention candidate, Phexxi, San Diego-based Evofem Biosciences Inc. has prevailed, winning FDA approval today for the vaginal pH regulator.