FDA

FDA Disapproves AP Pharma Nausea Drug

FDA Disapproves AP Pharma Nausea Drug

A. P. Pharma Inc. uncovered that U. S. health regulators disapproved its experimental drug designed to treat nausea and vomiting induced by chemotherapy, revealing concerns related to the drug's administration system.

FDA Approves First Totally Implanted Hearing Aid

Envoy Medical Corporation

The advanced implanted hearing system is the revealed to be the first completely implanted system which has grabbed an approval by the U. S. Food and Drug Administration for adults suffering from moderate-to-severe sensorineural hearing loss, a permanent lack of hearing.

A Twin Cities medical company can now market it merchandise.

Abbott Comes Out With A Safe And Effective Heart Valve Device

Abbott Laboratories experimental MitraClip

According to researchers Sunday, Abbott Laboratories experimental, minimally invasive heart valve device meant for repairing the commonest kind of heart valve problems, has met the primary goals of a pivotal study which found it to be safer and almost as effective as open heart surgery.
 

FDA Doubts Effectiveness of Medtronic’s DBS

Medtronic Inc

The U. S. regulators are expressing a doubt on whether the sales of Medtronic Inc.'s deep-brain stimulation system be curbed or not, in view of its dangerous outcomes like suicide, depression and attacks.

"The product failed to meet the study's primary goal of reducing the number of seizures after three months compared with a control group", stated the FDA.

Suspected Link Between Bisphosphonate and Thigh Fracture Ruled Out by FDA

US Food and Drug Administration

On Wednesday, the US Food and Drug Administration officials confirmed that they have not been able to find any link between bisphosphonate osteoporosis drugs, like Merck & Co Inc.'s Fosamax, and thigh bone fractures.

FDA Cracks Down Misleading Practices of Food Makers

FDA-LOGOThe Food and Drug Administration has issued warning letters to 17 manufacturers for carrying deceptive or false labels about nutrition and health benefits.

Nestlé and Other Food Makers Issued Letters by F.D.A.

FDA

On Wednesday, 17 warning letters were issued to food manufacturers by the Food and Drug Administration, which is considered to be an attack on deceptive labels on food packages.

FDA Announces an Initiative to Boost Regulatory Science

fda

The Food and Drug Administration and the National Institutes of Health on Wednesday unveiled an initiative to back the FDA extend swifter decisions regarding the safety and effectiveness of new products and procedures that flow from advanced research.

FDA Approves Pfizer for Pneumonia Vaccine

FDA Approves Pfizer for Pneumonia Vaccine

The U. S. Food and Drug Administration today extended an official approval to Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years.

It is a new version of a blockbuster vaccine that fights pneumonia, meningitis and other diseases caused by pneumococcus bacteria, a company spokeswoman said on Wednesday.

Avandia can Hurt the Heart, Stresses FDA

Avandia

Confidential reports of the American Government seem to suggest that GlaxoSmithKline Plc.'s diabetes drug Avandia should be pulled back from the market as it can end up hurting the heart, as has been speculated by some sources.

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