M2 Pharma - Research and Development

Symbiomix Therapeutics Receives FDA Approval for Solosec (secnidazole) Oral Granules for Treatment of Bacterial Vaginosis in Adult Women

19 September 2017 - - US-based biopharmaceutical company Symbiomix Therapeutics has received US Food and Drug Administration (FDA) approval for Solosec (secnidazole) 2g oral granules for the treatment...

FDA Approves Optinose's Xhance Nasal Spray for the Treatment of Nasal Polyps

19 September 2017 - - Yardley, Pennsylvania-based otolaryngology and allergy therapeutics developer Optinose has received approval from the US Food and Drug Administration (FDA) of its New Drug Applic...

Genentech Reports Positive Results of Venclexta Plus Rituxan in Patients with Previously Treated CLL Compared to Bendamustine Plus Rituxan

19 September 2017 - - South San Francisco, California-based biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has provided positive results from the Phase ...

Surmodics Receives FDA 510(k) and CE Mark Clearance for .014" PTA Balloon Catheter

19 September 2017 - - Eden Prairie, Minnesota-based medical device and in vitro diagnostic technologies provider Surmodics, Inc. (NASDAQ: SRDX) has received US Food and Drug Administration (FDA) 510(k...

First Mevion Proton Therapy System with Hyperscan Technology Installed at MedStar Georgetown University Hospital in Washington, DC

19 September 2017 - - Littleton, Massachusetts-based compact proton therapy solutions specialist Mevion Medical Systems has submitted its 510(k) Premarket Notification to the US Food and Drug Administ...

FDA Grants Masimo Clearance and Market Release of Pulse CO-Oximeter

19 September 2017 - - Irvine, California-based noninvasive monitoring technologies specialist Masimo (NASDAQ: MASI) has received FDA 510(k) clearance and full market release of Rad-97 Pulse CO-Ox...