US FDA Grants Orphan Drug Designation for Burzynski Research ... MarketWatch - "We are encouraged by the FDA's action. Initially, BRI sought orphan drug designation for ANP in optic pathway glioma in children, a much narrower ...

TransMolecular Reaches Special Protocol Agreement with FDA for an ... MarketWatch - Through the SPA, the FDA has agreed that if the (131)I-TM601 Phase 3 study successfully meets its stated endpoints, the design and planned analysis of the ...

MAKO Surgical Corp. Receives FDA Clearance to Market Both Its ... MarketWatch - "Obtaining the FDA 510(k) clearance for each of these products represents the achievement of a key milestone towards the continuing commercialization of ...

Current World News Novartis Malaria Drug Gets Favorable US FDA Review (Update3) Bloomberg - The FDA says tourism and military operations may spark domestic cases of malaria, which has all but disappeared in the US The agency has promised a voucher ... Malaria Treatment Very Close to Being Cleared by FDA FDA : Novartis malaria pill shows superior results Data supports Novartis malaria drug -US FDA staff

CTV.ca FDA Touts Efforts to Enhance Food Safety U.S. News & World Report, DC - What you could call the 'globalization of FDA ,' which is shifting our emphasis on inspection on the port of entry only to more of a product-lifecycle ... TFAH Statement: FDA Food Protection Plan is Insufficient FDA Details Its Food Safety Campaign FDA Activities Do Not Adequately Protect Food -

Deadlines for other inhalers to go eco-friendly FOXNews - While a final decision is pending, the FDA says that deadline would give sufficient time to reformulate and that there are good alternatives for each ... Asthma inhalers to go 'green' on Dec. 31 Asthma patients must go green Asthma Inhalers Scheduled to Go Green, Become More Expensive

White Paper Addresses FDA Approval Challenges Facing Combination ... MarketWatch - "The combination products market is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements," said Richter. ...

Innovative IV Catheter Receives FDA Clearance and Secures Funding ... MarketWatch - ... Ltd. Flexicath received a 510(k) clearance from FDA in October, allowing it to place its FirmGrip(TM) sterile catheter intravenous (IV) system in the US ... Zitelman Group invests in Israel firm

FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream MarketWatch - today announced that the US Food and Drug Administration ( FDA ) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for ... FDA approves new cream for vaginal dryness, pain Barr receives FDA approval for cream New cream for vaginal dryness approved

Cell Therapeutics gets FDA priority review on drug CNNMoney.com - The priority review designation cuts the expected review time at the FDA to 6 months from 10 months. The Seattle company expects a decision by April 2. ... FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review FDA speeds up review of Cell Therapeutics drug Allos cancer drug candidate gets FDA orphan status -