Inbox Robot: FDA Approvals News http://www.inboxrobot.com/news/fda-approvalsConstantly updated news and information about a variety of topics. BioForm Reports Financial Results for the Fourth Quarter and Full Fiscal Year Ended June 30, 2008 http://www.inboxrobot.com/news.php?fid=186695241 5 Sep 2008 17:34 GMT ... 2009. -- RADIESSE(R) Dermal Filler Post-Market Studies: The Company has completed and submitted to FDA the results of two post-approval studies for RADIESSE filler -- a three-year post-approval open-label follow-up to the pivotal nasolabial ... Abraxis and ProMetic Enter License Agreements for up to $295 M US for Four Biopharmaceuticals http://www.inboxrobot.com/news.php?fid=186695223 5 Sep 2008 17:34 GMT ... will fund all development costs to regulatory approval. The licensed products will be manufactured by ... known as the nab(TM) platform. The first FDA approved product to use this nab(TM) platform, ABRAXANE(R), ... Techalt, Inc.'s Stan's Rodeo Ointment (SRO) has Successful Introduction at the 2008 Beijing Olympics http://www.inboxrobot.com/news.php?fid=186694756 5 Sep 2008 17:34 GMT ... Games. SportPharm, SRO's compounder, and a U.S. Food and Drug Administration ("FDA") licensed distributor, and subsidiary of HNP ... securing contracts and obtaining over the counter approval from the FDA. Techalt is a public holding company structured ... Data Suggest CEL-SCI's CEL-2000 Vaccine Prevents or Retards Permanent Damage of Rheumatoid Arthritis http://www.inboxrobot.com/news.php?fid=186694375 5 Sep 2008 17:33 GMT ... a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III ... be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's ... TherOx, Inc. Announces Filing of a Registration Statement for Proposed Initial Public Offering of It http://www.inboxrobot.com/news.php?fid=186689455 5 Sep 2008 17:15 GMT ... muscle in acute heart attack patients. TherOx's Supersaturated Oxygen System has not yet received FDA approval and is currently limited by United States law to investigational use only. Contact: Kevin ... Lifeline Biotechnologies, Inc. Reorganizes Outstanding and Reduces Authorized Shares http://www.inboxrobot.com/news.php?fid=186689334 5 Sep 2008 17:15 GMT ... Systems(TM) interpretive, proprietary software, clinical trials and FDA pre-marketing clearance. Additional information can be obtained ... the Company's product and regulatory and shareholder approval for anticipated actions. ... Synageva BioPharma Appoints Sanj K. Patel President and Chief Executive Officer and Opens New Corporate Headquarters http://www.inboxrobot.com/news.php?fid=186688610 5 Sep 2008 17:12 GMT ... Genzyme Products. Sanj also led the Fabrazyme(R) clinical operations team and development program to FDA approval in April 2003. Sanj Patel also held clinical research and commercial development roles over ... InvestSource, Inc.: Cardio Infrared Technologies, Inc. Announces Launch of New Website http://www.inboxrobot.com/news.php?fid=186688152 5 Sep 2008 17:11 GMT ... successful End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) on August 29, 2008. Following a ... of mildly infected diabetic foot ulcers, the FDA agreed: * Oculus may move forward into ... studies will not be required for product approval. * Clinical requirements for efficacy and safety ... Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351 http://www.inboxrobot.com/news.php?fid=186686977 5 Sep 2008 17:02 GMT ... years, tax credits, and a waiver of FDA user fees. "The decision by FDA to ... pipeline of combination therapies involving both previously approved and novel drug agents. For more information, ... Elan and Biogen Idec Initiate First Clinical Trial of Tysabri in Oncology http://www.inboxrobot.com/news.php?fid=186681770 5 Sep 2008 16:37 GMT ... plasma cell disorders. TYSABRI is a treatment approved for relapsing forms of MS in the ... adequately address concerns or questions raised by FDA or other regulatory authorities, that concerns may ... Aethlon Medical Releases Shareholder Letter http://www.inboxrobot.com/news.php?fid=186681710 5 Sep 2008 16:37 GMT ... complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and ... Renowned PRO Experts, Bio-IT World Editor-in-Chief to Keynote PHT's Educational ePRO Conference http://www.inboxrobot.com/news.php?fid=186681324 5 Sep 2008 16:36 GMT ... case studies on pertinent topics such as FDA audits, PRO validation, adaptive trials and the ... successfully in at least seven known NDA approvals to date. For more information, review interactive ... --> Renowned PRO Experts, Bio-IT World Editor-in-Chief to Keynote PHT's Educational ePRO Conference http://www.inboxrobot.com/news.php?fid=186681146 5 Sep 2008 16:36 GMT ... Industry Providers to Detail Real-World Experiences With FDA Audits, PRO Validation, Adaptive Trials, Site Perspective ... successfully in at least seven known NDA approvals to date. For more information, review interactive ... Altria in Talks to Buy UST for $10 Billion http://www.inboxrobot.com/news.php?fid=186679147 5 Sep 2008 16:31 GMT ... create tobacco products that are lower risk than regular cigarettes. The House has already approved legislation that would allow the Food and Drug Administration to regulate tobacco products. The measure, which the White House opposes, is expected to ... Let's talk alternative healing http://www.inboxrobot.com/news.php?fid=186678860 5 Sep 2008 16:31 GMT ... potentially harmful or just plain quackery. Like Good Housekeeping, they want their AMA or FDA seal of approval. There is a fear of drawing outside the lines. And, to give the White ...