FDA Extends Review of Somaxon Pharmaceuticals' New Drug

Somaxon cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements. For example, statements regarding the potential
approval of the NDA for Silenor and the potential commercialization of
Silenor are forward looking statements. The inclusion of
forward-looking statements should not be regarded as a representation by
Somaxon Read the rest of this entry »

VioQuest Pharmaceuticals Receives 510(k) Response from FDA for Xyfid™

BASKING RIDGE, N.J.–(
)–VioQuest Pharmaceuticals (OTCBB: VOQP) today announced that it has
received a determination from the U.S. Food and Drug Administration
(FDA) that Xyfid
(1% uracil topical) is a
drug rather than a device and would be regulated with the Center for
Drug Evaluation and Research (CDER) as opposed to the Center for Devices
and Radiologic Health (CDRH).
“Beginning in 2008, we initiated parallel Read the rest of this entry »

Watson Pharmaceuticals Receives FDA Approval for Mint Coated

CORONA, Calif.
,
Dec. 31
/PRNewswire-FirstCall/ — Watson Pharmaceuticals, Inc. (NYSE:
), a leader in generic and specialty branded pharmaceuticals, today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavor, in the 2 mg and 4 mg strengths.
Nicotine Polacrilex Gum, coated mint flavor, Read the rest of this entry »

Amylin Pharmaceuticals, Inc Q4 2008 Earnings Call Transcript

Amylin Pharmaceuticals, Inc (
January 27, 2008 5:00 pm ET
Mark Foletta – SVP, Finance, and CFO
Good day, ladies and gentlemen, and welcome to the fourth quarter 2008 Amylin Pharmaceuticals Incorporated earnings conference call. My name is Stacey and I will be your conference moderator for today. (Operator Instructions)
I would now like to turn the presentation over to your host for today’s call, Mr. Michael York, Senior Director of Investor Read the rest of this entry »

Tons of pharmaceuticals dumped into wastewater, study finds

Tons of pharmaceuticals dumped into wastewater, study finds
12:00 AM CDT on Monday, September 15, 2008
Jeff Donn, Martha Mendoza, and Justin Pritchard, The Associated Press
U.S. hospitals and long-term care facilities annually flush millions of pounds of unused pharmaceuticals down the drain, pumping contaminants into America’s drinking water, according to an ongoing Associated Press investigation.
These medications are expired, spoiled, Read the rest of this entry »

Pro-Pharmaceuticals Submits Data to FDA for DAVANAT ® NDA to Treat

NEWTON, Mass.–(
Pro-Pharmaceuticals, Inc.
(AMEX: PRW), a bio-pharmaceutical
company developing proprietary polysaccharide-based therapeutic
compounds to treat cancer, has submitted supporting clinical and
manufacturing data to the U.S. Food and Drug Administration (FDA) for a
New Drug Application (NDA) registration of DAVANAT
,
a new chemical entity, for the treatment of advanced colorectal cancer.
Read the rest of this entry »

AMAG Pharmaceuticals Receives Complete Response Letter from FDA

LEXINGTON, Mass.–(
)–AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has
received a complete response letter from the U.S. Food and Drug
Administration (FDA) for ferumoxytol for the treatment of iron
deficiency anemia in chronic kidney disease patients. The Company
submitted its New Drug Application for marketing approval of ferumoxytol
in December 2007.
The Company believes that it can address Read the rest of this entry »

BioSante Pharmaceuticals Announces Issuance of New Patent Covering

LINCOLNSHIRE, Ill.–(Business Wire)–
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced that a new patent has
issued covering Elestrin (estradiol gel), which is approved in the U.S. for
moderate-to-severe vasomotor symptoms, known as hot flashes, associated with
menopause. BioSante received approval of Elestrin from the U.S. Food and Drug
Administration (FDA) in December 2006.

U.S. Patent 7,470,433 issued on December 30, 2008, and is expected Read the rest of this entry »

Altus Pharmaceuticals Announces Presentation of Phase 3 Trizytek

The statements in this press release regarding the assessment of the
Phase 3 data and its implications for remaining Phase 3 trials, the
future development of Trizytek, and our ability to file an NDA and the
timing of any filing of an NDA with the FDA for Trizytek are
forward-looking statements that are subject to risks and uncertainties
that could cause actual results to differ materially from those
Read the rest of this entry »

Rexahn Pharmaceuticals announced today that the Company has

Rexahn Pharmaceuticals announced today that the Company has received FDA approval to begin Phase II trials for Serdaxin(TM), for the treatment of major depressive disorders (MDD)
ROCKVILLE, MD, USA | September 10, 2008 |
Rexahn Pharmaceuticals, Inc. (AMEX: RNN – News), a leader in innovative therapeutics for life-threatening and life-debilitating diseases, announced today that the Company has received FDA approval to begin Phase II trials for Read the rest of this entry »