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.
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, EMA, FDA, House Energy and Commerce Subcommittee on Oversight and Investigations, International Coalition of Medicines Regulatory Authorities, National Institutes of Health, Trump administration, World Health Organization.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4DMedical, Bardy Diagnostics, Beyond Air, Merit Medical, Orteq Sports Medicine, Philips, Smart Medical Systems, United Imaging.