Abbott (NYSE: ABT) announced today it has received U.S. Food and Drug Administration (FDA) approval for the TECNIS® Multifocal 1-Piece intraocular lens (IOL) for cataract patients with and without presbyopia. Intraocular lenses are...

Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), announced that the U.S. Food and Drug Administration (FDA) recently accepted for review the lurasidone New Drug Applicat...

(March 11, 2010 05:40 AM, by David Henderson) Which group should the U.S. Food and Drug Administration care about more: humans or rats? That's not a trick question. The FDA's recent decision to reject the drug Horizant suggests that...

An expert calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration, and how the FDA represents this informat...

The World Health Organization and the US Food & Drug Administration have decided on the composition of the influenza virus vaccine that will be used during the 2010-2011 season in the northern hemisphere.

WASHINGTON — The Food and Drug Administration said Tuesday it approved Allergan's botulinum-based drug Botox to treat spasms of the elbow, wrist and fingers. Botox...

Major Movement, Analyst Reports, Analyst Upgrades and Downgrades, Good news, Products and ServicesLate Tuesday, an advisory panel of the Food & Drug Administration (FDA) voiced its approval for pirfenidone, the experime...

The U.S. Food and Drug Administration approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progr...

biospace med announced today that it has received 510(k) clearance from the FDA (Food and Drug Administration) to market the Company's sterEOS 2D/3D workstation for pediatric use in spine applications. The Company's EOS ultra-low-do...

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, announced that the US Food and Drug Administration (FDA)...

optionMONSTER submits: By Jon Najarian FDA Decision on Byetta Due Friday On Friday, Amylin (AMLN) and partner Eli Lilly (LLY) are expected to get a decision by the Food and Drug Administration on Byetta, its once-a-week treatment fo...

Axis Surgical Technologies, Inc., announced that it has received 510(k) clearance from the Food and Drug Administration to market their C-MOR™ Visualization Device for use in diagnostic and operative arthroscopic and endoscopic proc...

Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced that the U.S. Food and Drug Administration has granted Fenwal 510(k) clearance to market its Ami...

Zacks.com submits: In a positive development, Cell Therapeutics (CTIC) announced that the US Food and Drug Administration ((FDA)) has completed its inspection of the company’s manufacturing facility in Italy and found it to be c...

MicroPhage announced that it has submitted human data from a pivotal clinical study of its 'Microphage MRSA/MSSA Blood Culture Test' to support a U.S. Food and Drug Administration (FDA) 510(k) premarket notification process. The fir...

A group of US Senators led by Senator John Kerry, is urging the Food and Drug Administration to lift the ban preventing gay men from donating blood. The ban was put into place at the height of the HIV scare at a time when the diseas...

CSL Behring announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for HizentraTM, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (P...

The Obama administration is vexed that 'mutual respect' and 'honest engagement' have failed to persuade Jamaica to extradite an alleged drug kingpin.

InterMune, Inc. (Nasdaq: ITMN) announced that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (N...

The U.S. Food and Drug Administration is taking steps to protect the public following the early identification of Salmonella Tennessee in one company's supply of hydrolyzed vegetable protein (HVP). This is a common ingredient used m...