Two recent FDA approvals have prompted the National Comprehensive Cancer Network (NCCN) to update the NCCN Clinical Practice Guidelines in Oncology(TM) for Non-Hodgkin’s Lymphomas to include ofatumumab (Azerra(TM), GlaxoSmithKline) and romidepsin (Istodax(R), Gloucester Pharmaceuticals) as treatment options for select patients with two types of Non-Hodgkin’s Lymphomas. ...

... and Adverse Event Reporting Program PRODUCT APPROVALS: FDA Approves Drug Treatment for Rare Cancer ... programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. ... ? support@govdelivery.com Other inquiries? webmail@oc.fda.gov GovDelivery, Inc. sending on behalf of U.S ...

... a growth and distribution phase, investors are preoccupied with waiting on pending FDA approvals and I don't expect to see the stock move much until/if those ... . As far as investors are concerned, we should consider nothing a done deal until it's a done deal - and so far FDA approval is not a done deal. That being said, I still consider ActiPatch a product with huge potential to catch on ...

... "What's the next steps?" If you are like me, you expect FDA to issue new guidance. My friend John Murray ... guidance here. But some of us are anxious to see if stakeholders can get more involved in the process. For example, does the FDA plan to pull in any outside consultants, or hire additional ... fast-track drug approvals, pharmaceutical company user fees, and the FDA way! Let's join ...

According to MassDevice.com, the online business journal of the medical device industry, medical device approval times under the Food & Drug Administration's 510(k) clearance process jumped 30 percent between 2005 and 2008. MassDevice's exclusive investigation of 10 years of FDA data,

... or comes back after at least one other type of chemotherapy has been used. “This approval demonstrates FDA’s commitment to the development and approval of drugs for rare and uncommon diseases,” said ... FDA’s Center for Drug Evaluation and Research. The FDA approved Istodax on Nov. 6, 2009. Previous approvals for CTCL included Zolinza (vorinostat), Ontak (denileukin difitox), and Targretin ...

... Boston Globe slams DSHEA and 'powerless' FDA Big gaps in US food-borne illness response ... Boston Globe slams DSHEA and 'powerless' FDA TheBoston Globe has called for a repeal of DSHEA, stating that ... PREVIOUS HEADLINES Three speedy GM maize approvals ease soy imports The European Commission last week ...

... ?  In short answer, yes.  Mylan’s future comes from a swath of FDA approvals that have come in over the past few months. August 27, 2009 Mylan ... 18, 2009 Mylan’s Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV ... Imitrex(R) July 20, 2009 Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol— Key ...

... nucleic acid extract can be tested with any combination of its other products which have received FDA clearance – ProFlu Plus, Pro hMPV Plus and ProFlu-ST. As a reminder, ProFlu Plus received FDA approval in 2008 for detecting and differentiating influenza A and ... of the NAT technology has enabled the company to obtain FDA approvals for more than 40 products that detect a wide variety of ...

... With the international controversy surrounding hydroquinone and the proposed ban tabled by the FDA, the need for a safe and effective skin brightener is pressing. Lumixylâ„¢ was ... science industry. His efforts have led to 2 acquisitions, over a dozen FDA-approvals, more than 40 patents, and some 75 peer-reviewed publications. Dr. Hantash completed his dermatology residency, postdoctoral training in ...