PHILADELPHIA, Jan. 29 /PRNewswire/ — GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral t…
WASHINGTON (Reuters) – The number of U.S. Food and Drug Administration warnings to drugmakers and others for questionable drug promotion has nearly doubled since President Barack Obama took office a year ago, a top FDA official said on Friday.
FDA inspection shows devices produced under poor manufacturing condition; pose public health risk
SILVER SPRING, Md., Jan. 29 /PRNewswire-USNewswire/ — At the request of the U.S. Food and Drug Administration, U.S.
PITTSBURGH, Jan. 29 /PRNewswire-FirstCall/ — Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (AND…
CARLSBAD, Calif., Jan. 28 /PRNewswire/ — Aubrey Inc., an advanced wound care company, announced it has received clearance from the US Food and Drug Administration (FDA) to market the AWBAT Plus product line in the United States. This represents a sign…
The U.S. Food and Drug Administration recalled over two million needles made by Japanese firm Nipro Medical Corp. over fears they might introduce silicone fragments in patients’ bodies.
PRINCETON, N.J., Jan. 27 /PRNewswire/ — Church & Dwight, Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the FIRST RESPONSE® Early Result Pregnancy Test which can determine pregnancy up to six days befor…
COLUMBUS, Ohio, Jan. 26 /PRNewswire/ — Roxane Laboratories, Inc. announced today the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL bottles as of January 25th, 2010 by the Food and Drug Ad…
The U.S. Food and Drug Administration announced the recall of two million medical needles Tuesday because of a risk they can push bits of silicone into patients’ bodies.
SILVER SPRING, Md., Jan. 26 /PRNewswire-USNewswire/ — If you want to quit smoking, you’ll need willpower — and perhaps the aid of a product that’s intended to help you beat the addiction.
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