Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for the fixed-dose combination therapy...
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced that it has submitted a Marketing Authorization Application (MAA) to the Japanese Ministry of Health, Labour and Welfare seeking approval for SEP-190 (generic name: eszopiclone), a product the company has been...
Ethicon, Inc., a worldwide leader in surgical care, announced that the company has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human...
Nanotherapeutics, Inc., announced that it has filed an Investigational New Drug (IND) Application with the Food and Drug Administration (FDA) for NanoDTPA™ an orally administered capsule that is a less invasive treatment alternative to the FDA approved injectable Zn-DTPA (diethylenetriamine...
Biodel, Inc. (Nasdaq: BIOD) announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes. VIAject® is Biodel's proprietary formulation of recombinant human insulin that is designed to be...