Content about Food and Drug Administration

March 11, 2010
FDA adds boxed warning to Plavix

A popular drug for preventing blood clots may be less effective when taken by a...

March 11, 2010
Watson gets FDA approval for Trelstar

The Food and Drug Administration has approved a Watson Pharmaceuticals drug for treating cancer, Watson...

March 10, 2010
Bayer receives orphan drug designation for CF treatment

The Food and Drug Administration has given orphan drug designation to an investigational treatment for...

March 10, 2010
FDA accepts approval application for lurasidone

The Food and Drug Administration has accepted an approval application for a new drug to...

March 9, 2010
FDA committee recommends approval for InterMune’s Esbriet

A Food and Drug Administration committee has recommended approval for an investigational drug for treating...

March 8, 2010
GPhA hopes Office of Generic Drugs gets more funding from Congress

An organization representing the generic drug industry is hoping that Congress gives the Food and...

March 8, 2010
Watson seeks approval for generic Opana

Watson Pharmaceuticals has filed a regulatory approval application for a generic version of a painkiller...

March 7, 2010
Taro receives FDA approval for skin cancer generic

The Food and Drug Administration has approved Taro Pharmaceutical Industries’ generic version of a drug...

March 4, 2010
FDA reviewing InterMune's IPF drug

The Food and Drug Administration is reviewing a drug for treating a lung condition that...

March 4, 2010
Report: Office of Generic Drugs head steps down

The head of the Food and Drug Administration’s generic drug division is stepping down to...

March 3, 2010
Shire given market exclusivity for ADHD drug

The U.S. District Court for the District of Columbia has upheld a decision by the...

March 2, 2010
FDA issues complete response letter to Bristol-Myers Squibb

The Food and Drug Administration has declined to approve a biotech drug for organ transplant...

March 2, 2010
FDA survey notes increased awareness of diet, heart disease link

Consumers who often read food labels are increasingly aware of the link between diet and...

March 2, 2010
Norditropin FlexPro receives FDA approval

The Food and Drug Administration has approved a Novo Nordisk treatment for growth hormone disorders,...

March 1, 2010
FDA approves extended-release painkiller

The Food and Drug Administration has approved a regulatory approval application for a pain drug...

March 1, 2010
FDA approves Mylan's generic version of gallstones treatment

The Food and Drug Administration has approved Mylan’s generic version of a gastrointestinal drug, Mylan...

March 1, 2010
FDA committee recommends kidney transplant drug be approved

The Food and Drug Administration has recommended approval for a biotech drug for treating kidney...

March 1, 2010
Impax Labs receives FDA approval for generic tamsulosin

The Food and Drug Administration has approved the first generic version of a drug for...

February 28, 2010
FDA accepts regulatory application for Qnexa

The Food and Drug Administration has accepted a regulatory approval application for a drug to...

February 28, 2010
FDA, EMEA adopt orphan drug report system

Companies developing drugs to treat especially rare conditions may find winning regulatory approval in the...

February 28, 2010
Merck's R&D pipeline gets a boost

Merck & Co.’s acquisition of Schering-Plough has delivered a big boost to the drug maker’s...

February 28, 2010
Senators seek new supplement regulations

Former presidential candidate Sen. John McCain, R-Ariz., and Sen. Byron Dorgan, D-N.D., last month introduced...

February 25, 2010
FDA approves Shire's Type 1 Gaucher disease

The Food and Drug Administration has approved a new drug for treating a rare genetic...

February 23, 2010
FDA committee recommends approval of Xifaxan

A Food and Drug Administration committee has recommended approval for a drug to treat a...

February 23, 2010
FDA, NIH announce new partnership

The Food and Drug Administration and the National Institutes of Health hope to accelerate the...

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