food and drug administration

Diet Treatment, Already in Use, to Get F.D.A. Review

NYT > Business  Thu, 02/16/2012 - 22:15

The Food and Drug Administration will review a new diet pill consisting of a combination of two pills people are using in California to lose weight.


 

Mead Johnson Says Its Tests Show Enfamil Baby Formula Is Safe

Topix - Business News  Mon, 12/26/2011 - 06:58

Mead Johnson Nutrition Co. said tests it conducted on samples of its Enfamil baby formula tied to an U.S. Food and Drug Administration investigation found no presence of bacteria.


 

After-Hours Movers 10/19: (NEOP) (RVBD) (SCSS) (CBST) Higher; (P...

StreetInsider.com News Articles  Wed, 10/19/2011 - 16:15

Neoprobe Corporation (NYSE: NEOP) 19.5% HIGHER; today announced that its New Drug Application (NDA) for Lymphoseek has been accepted for review by the U.S.

Food and Drug Administration. Neoprobe submitted the Lymphoseek NDA on August 10, 2011. Polycom, Inc. (NASDAQ: PLCM) 17% LOWER; reported Q3 non-GAAP EPS of $0.26, $0.01 worse than the analyst estimate of $0.27.

Revenue for the quarter came in at $379 million versus the consensus estimate of $388.35 million. Riverbed Technology, Inc.


 

Unusual 11 Mid-Day Movers 09/26: (MELA) (ZN) (GNRC) Higher; (EK)...

StreetInsider.com News Articles  Mon, 09/26/2011 - 11:05

MELA Sciences (Nasdaq: MELA) 56.3% HIGHER; reports the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter for the MelaFind Pre-Market Approval (PMA) application.

Eastman Kodak Co.


 

Unusual 11 Mid-Day Movers 08/12: (TXCC) (MNKD) (MDS) Higher; (FR...

StreetInsider.com News Articles  Fri, 08/12/2011 - 11:19

TranSwitch Corporation (Nasdaq: TXCC) 23.4% HIGHER; announced that the Company's HDMI 1.4 Intellectual Property with patented Phaswitch" technology has been selected by Samsung Electronics for its next generation of televisions.

Also notably, the stock bounced sharply off the 200-day SMA earlier. MannKind Corporation (Nasdaq: MNKD) 21.5% HIGHER; confirms with the U.S.

Food and Drug Administration the design of two clinical studies that evaluate the efficacy and safety of AFREZZA (insulin human [rDNA origin]).


 

Pew finds serious gaps in oversight of US drug safety

http://www.eurekalert.org/rss/business.xml  Mon, 07/11/2011 - 22:00

(Pew Health Group) Americans' medicines are increasingly manufactured in developing countries, where oversight is lower than in the US, according to a new white paper by the Pew Health Group.

The US Food and Drug Administration (FDA) estimates 40 percent of finished drugs and 80 percent of active ingredients and bulk chemicals used in US drugs come from overseas.


 

FDA recommends lower doses of anemia drugs

Newsvine - business  Fri, 06/24/2011 - 10:00

Food and Drug Administration officials say doctors should use lower doses of anemia drugs when treating patients with failing kidneys due to the increased risk of stroke, blood clots and death.


 

Pfizer, Acura say FDA clears painkiller Oxecta

Newsvine - business  Mon, 06/20/2011 - 07:15

Pfizer Inc. and Acura Pharmaceuticals Inc. say the Food and Drug Administration approved a powerful painkiller that is designed to be harder to abuse.


 

Teva gets US OK for generic Alzheimer's drug

Newsvine - business  Wed, 06/01/2011 - 14:48

The U.S. Food and Drug Administration has approved Teva Pharmaceutical Industries Ltd. to sell a generic version of blockbuster Alzheimer's drug Aricept.


 

GAO renews critique of FDA medical device system

Newsvine - business  Wed, 04/13/2011 - 10:53

Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same speedy system intended for power wheelchairs, stitches and catheters.