FDA NEWS

Panel cites benefits of Pfizer osteoporosis drug - San Diego Union-Tribune
WASHINGTON – An experimental drug from Pfizer could benefit certain women with osteoporosis, federal advisers said Monday, despite concerns of side effects. A Food and Drug Administration panel of experts voted 9-3 that the benefits of Fablyn could
Source: www.signonsandiego.com

Pfizer takes more time with antibiotic application - CNBC
NEW YORK - Pfizer Inc. said Tuesday it will withdraw approval requests for the antibiotic dalbavancin and conduct another late-stage clinical trial before reapplying. The drug is being developed as a treatment for antibiotic-resistant skin infections
Source: www.cnbc.com

Remicade tagged with stronger warning. - Pottstown Mercury
WASHINGTON - The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections. The drugs
Source: www.pottstownmercury.com

US FDA panel backs Pfizer osteoporosis drug - Guardian Unlimited
ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease osteoporosis. The committee voted 9-3 that the drug
Source: www.guardian.co.uk

Cardica gets FDA approval for surgical system - Forbes
Surgical systems maker Cardica Inc. said Tuesday the Food and Drug Administration approved its PAS-Port system for use in cardiac bypass surgery. The system creates a secure connection between the body's main artery and vein grafts. Cardiac bypass
Source: www.forbes.com

Pfizer Bone Drug Benefits Outweigh Risks, Panel Says (Update2) - Bloomberg
Sept. 8 (Bloomberg) -- Pfizer Inc. 's Fablyn, an experimental treatment for women with weak bones, has benefits that outweigh its risks, U.S. advisers said. The Food and Drug Administration panel made the recommendation for postmenopausal women with
Source: www.bloomberg.com

UPDATE 1-Cardica gets FDA nod for bypass surgery device - Reuters
Sept 9 (Reuters) - Cardica Inc (CRDC.O: Quote , Profile , Research , Stock Buzz ) said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent
Source: www.reuters.com

Cardica gets FDA nod for bypass surgery device - Forbes
- Sept 9 (Reuters) - Cardica Inc said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent before the bell. The medical device maker said
Source: www.forbes.com

UPDATE 2-US FDA panel backs Pfizer osteoporosis drug - Reuters
ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc (PFE.N: Quote , Profile , Research , Stock Buzz ) drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease
Source: www.reuters.com

FDA panel mixed on Pfizer bone drug risks - Reuters UK
ROCKVILLE, Maryland (Reuters) - Members of a U.S. advisory panel said on Monday they could not determine if a proposed Pfizer Inc drug for osteoporosis increased the chances of dying. Seven members of the Food and Drug Administration committee said
Source: uk.reuters.com