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Your search for U.S. Food and Drug Administration (FDA) in News Releases returned 6 results

News Releases

• May 18, 2013, 12:00 ET

  Takeda And Lundbeck Present Results From Pivotal Phase 3 Clinical Trials With Vortioxetine, An Investigational Compound For Major Depressive Disorder

   Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced that the companies will be presenting new data from four studies that evaluated effectiveness in treating the overall symptoms of depression in patients taking vortioxetine, an investigational agent...

  More news about: Takeda Pharmaceutical Company Limited , Lundbeck , U.S. Food and Drug Administration (FDA)

• May 01, 2013, 12:07 ET

  Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. Food and Drug Administration

   Janssen Research & Development, LLC (Janssen) announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome...

  More news about: Janssen Research & Development , U.S. Food and Drug Administration , FDA , Genmab A/S , Janssen Biotech, Inc.

• Apr 16, 2013, 10:13 ET

  New White Paper Details What Compounding Pharmacies Must Know to Prepare for FDA Inspections

   In anticipation of new US Food and Drug Administration (FDA) regulations, many companies are working toward correcting potential problems and attaining USP <797> compliance. A new white paper addresses the issues that compounding pharmacies must address prior to undergoing an FDA or...

  More news about: Microtest Laboratories , US Food and Drug Administration (FDA)

• Apr 16, 2013, 09:30 ET

  Aethlon Medical (AEMD) Note: New Government Contract, Resubmission of IDE to Treat Hepatitis C (HCV), Biothreat Legislation Signed into Law by President Obama

   Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce. As disclosed in yesterday's SEC form 8-K submission, we entered into a subcontract agreement with Battelle Memorial Institute (Battelle) to provide services underlying a $22.8...

  More news about: Aethlon Medical, Inc. , Battelle Memorial Institute , Defense Advanced Research Projects Agency , DARPA , U.S. Food and Drug Administration , FDA

• Apr 11, 2013, 08:00 ET

  MAQUET Cardiovascular Receives FDA 510(k) Clearance And CE Mark Approval For AIR-BAND™ Radial Compression Device

   MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and European CE mark approval for its new AIR-BAND™ Radial Compression Device. Indicated to assist...

  More news about: MAQUET Cardiovascular LLC , U.S. Food and Drug Administration , FDA

• Apr 01, 2013, 08:00 ET

  Actavis Confirms Generic AndroGel® 1.62% Patent Challenge

  

   Actavis, Inc. (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Gel, 1.62%.  Actavis' ANDA product is a generic version of AbbVie Inc.'s AndroGel ® 1.62%,...

  More news about: Actavis, Inc. , U.S. Food and Drug Administration (FDA) , AbbVie Inc. , Unimed Pharmaceuticals, LLC , Besins Healthcare Inc.