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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 17, 2013, 08:00 ET

Thoratec Announces FDA Approval Of HeartMate II® Pocket Controller™

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...

More news about: Thoratec Corporation , U.S. Food and Drug Administration
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, 09:32 ET

FDA Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment

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...

More news about: Charleston Laboratories, Inc. , U.S. Food and Drug Administration
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 08, 2013, 07:30 ET

Bausch + Lomb Receives FDA Approval for PROLENSA™ (bromfenac ophthalmic solution) 0.07%

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...

More news about: Bausch + Lomb , U.S. Food and Drug Administration
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.
Mar 28, 2013, 17:00 ET

Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C

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...

More news about: Janssen Research & Development, LLC , U.S. Food and Drug Administration
Mar 22, 2013, 15:31 ET

Eggs, Spring and Food Poisoning

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