U.S. Food and Drug Administration

U.S. Food and Drug Administration Articles

Repligen Corporation (NASDAQ: RGEN) may be the biotech implosion of the day if the volume starts to catch up to some pre-market trading levels.  The company received a complete response letter from...
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) was already on the radar screens in biotech before this morning.  But news showing that the company’s cancer drug carfilzomib has received favorable FDA...
Celgene Corporation (NASDAQ: CELG) is supposed to be one of the more promising biotechs out there.  After all it was worth some $29.6 billion in market capitalization at Wednesday’s close.  Now...
We are tracking and analyzing a significant volume spike in shares of Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today.  Shares are up nearly 5% at $8.25 and the 12:30 PM trading volume is now over...
Cell Therapeutics, Inc. (NASDAQ: CTIC) is about as controversial of a biotech stock as there can be.  It often traded huge volume around drug approval or study news, and shares rose after being...
ViroPharma Incorporated (NASDAQ: VPHM) is getting crushed on news that the Food & Drug Administration has denied the petition filed by ViroPharma on March 17, 2006 related to the FDA’s proposed...
VIVUS Inc. (NASDAQ: VVUS) is getting a bit of a haircut this morning on the heels of some news from the Food & Drug Administration which may throw up some caution for its weight loss pill. The...
There is good news and bad news on Thoratec Corporation (NASDAQ: THOR) today.  The bad news is that it did have a FDA news recall of its HeartMate II® Left Ventricular Assist System.  The good...
Thoratec Corporation (NASDAQ: THOR) took it on the chin today after news came out about the Food & Drug Administration recalling the company’s HeartMate II as the left ventricular-assist...
Chelsea Therapeutics International Ltd. (NASDAQ: CHTP) is being beaten hard this morning.  News hit that the FDA has now rejected the company’s Northera drug to treat low blood pressure for now in...
Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) and Eli Lilly & Co. (NYSE: LLY) are in the news on the diabetes front.  The companies have announced that the European Commission has now approved its...
The Food and Drug Administration approval of the first generic versions of osteoporosis drug Boniva won’t be the end of Roche Holding AG (OTC: RHHBY) for its marketing of Boniva in the United...
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) has been one of the top performing stocks of 2012.  Not just in emerging pharma and in biotech, but across the board.  Now we have some more good news...
Instead of admitting that it has, in the past, sold food with too much sodium, salt and sugar, Walmart (NYSE: WMT) has made a public relations bonanza of its decision to sell more healthy food. The...
Pfizer Inc. (NYSE: PFE) has a big day ahead of it.  While it has been known for years, it is a massive date: Lipitor goes off-patent and will have generic versions of the statin drug competitors....