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May 18, 2013, 12:00 ET
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...
May 17, 2013, 08:00 ET
Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the HeartMate II® Pocket...
May 01, 2013, 12:07 ET
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...
Apr 16, 2013, 10:13 ET
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...
Apr 16, 2013, 09:32 ET
Charleston Laboratories, Inc, an emerging specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting related to opioid analgesics and other pain associated disease states, announced today the U.S. Food...
Apr 16, 2013, 09:30 ET
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...
Apr 11, 2013, 08:00 ET
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...
Apr 08, 2013, 07:30 ET
Bausch + Lomb, the global eye health company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for PROLENSA™ (bromfenac ophthalmic solution) 0.07 percent prescription eye drop, an innovative once-daily nonsteroidal...
Apr 01, 2013, 08:00 ET
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%,...
Mar 28, 2013, 17:00 ET
Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily...
Mar 22, 2013, 15:31 ET
The egg has been associated with festivals celebrating spring for many centuries. Decorating eggs for Easter is a tradition that dates back to the 13th century or earlier. Eggs were formerly a forbidden food during the Lenten season, and there are rituals in many countries involving...
More news about: U.S. Food and Drug Administration
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