Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: EMD Serono, Genprex, Medivir, Merck, Sinovac, Tizona, Viracta.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fulcrum, GBT, Hemoshear, Imara, Innate, Mayne, Medigene, Neurorx, Novartis, Relief, Philogen.
HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”
The latest global regulatory news, changes and updates affecting biopharma, including: Auromedics, Bring Entrepreneurial Advancements to Consumers Here In North America, Central Drugs Standard Control Organisation, FDA, Gilead Sciences, Medicines and Healthcare products Regulatory Agency, NIH, Pharmaceutical and Medical Devices Agency, Somerset, Therapeutic Goods Administration, U.S. Patent and Trademark Office.
Precardia Inc. received some good news from the U.S. FDA, which has granted the company's catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) breakthrough device designation. The device is intended to quickly reduce congestion in the venous system, known as cardiac preload, with an eye toward improving overall cardio-renal function.
Sommetrics Inc. said Tuesday that it has requested emergency use authorization from the U.S. FDA to market its Aersleep II device for sleep apnea patients at risk of COVID-19. The aim is to reduce the transmission of SARS-CoV-2, the virus that causes COVID-19, by treating infected patients with sleep apnea with Aersleep instead of continuous positive airway pressure (CPAP) therapy.