Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee"), announced today that it has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for Camcevi™ 42mg (FP-001 LMIS 50mg), a ready-to-use 6-month depot formulation of leuprolide mesylate.
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced that it had submitted its protocol to FDA for a clinical study to support marketing of the LuViva® Advanced Cervical Scan in the United States.
Phase 1 Trial for the Treatment of Patients with Acute Lung Injury Due to COVID 19 Anticipated to Begin in Third Quarter of 2020
FDA sets PDUFA date of December 30, 2020
28-day study in hospitalized patients with moderate COVID-19 symptoms
Expanded access is available to patients who are ineligible for enrollment in the FDA clinical trial of RLF-100, including pregnant women