Lupin Pharmaceuticals, Inc. (LPI) announced that it has received tentative approval from the US Food and Drug Administration (US FDA) for its Memantine Hydrochloride tablets, 5mg and 10mg.
Lupin’s Memantine HCl tablets are AB-rated to Namenda® tablets indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Namenda had annual sales of approximately [...]

Elbit Imaging Ltd. (NASDAQ: EMITF) (”Elbit” “Company”) that its subsidiary, InSightec Ltd., announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the company’s ExAblate(R) MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids.

Theralase Technologies Inc. (TSX VENTURE:TLT) announces revolutionary results of a pre-clinical study of its patented photodynamic compounds (PDCs) and their ability, when used with Theralase lasers, to destroy breast cancer cells. Theralase plans to submit results to the US Food and Drug Administration and Health Canada, as part of its collaborative work with Virginia Tech.

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena’s internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin’s clinical [...]

Agendia, a world leader in molecular cancer diagnostics, announced that the US Food and Drug Administration (FDA) cleared its MammaPrint breast cancer recurrence test for all ages. MammaPrint is the only FDA-cleared breast cancer recurrence test available to patients and physicians. Over the past three years, the FDA has issued four clearances for MammaPrint, covering [...]