SPPI.O
) said
U.S. regulators have extended the review date of its
experimental cancer drug, Zevalin, to July 2.
The decision by the U.S. Food and Drug Administration comes
after the regulator received a major amendment to the
Supplemental Biologics License Application for use of Zevalin
as a treatment for patients with indolent B-cell non-Hodgkin’s
lymphoma (NHL), the company said.
The drug has received priority review status from the FDA.
Read the rest of this entry »
Tags: cancer, Date, Drug, extends, Review, says, Spectrum Posted in Uncategorized | No Comments »
,
as a “fitness diary,” which paints a very accurate picture of what the iPhone and iPod touch app delivers. With an extensive database of food types and nutritional items along with a large variety of exercise types and styles, Absolute Fitness will allow you to track you nutritional intake and exercise levels on a day-to-day basis.
While not the easiest application to get around in, Absolute Fitness certainly delivers value in terms of Read the rest of this entry »
Tags: Absolute, Fitness, iPhone, Review Posted in Diet, Features, Fitness, Health, Health care | No Comments »
Shares of
plummeted Thursday evening after the company said federal regulators pushed back the target date to review the company’s treatment for gout.
Savient said in a statement the Food and Drug Administration has extended its review for the drug by three months until July 30. FDA also notified the company it will likely reschedule a meeting planned for March 5 to review the company’s drug.
Savient has asked the FDA to approve the injectable Read the rest of this entry »
Tags: Drug, extends, Gout, Review, time Posted in Uncategorized | No Comments »
Jan. 21 (Bloomberg) — U.S. regulators are examining
’s
health problems to ensure investors weren’t misled, a person
familiar with the matter said.
The Securities and Exchange Commission’s review doesn’t
mean investigators have seen evidence of wrongdoing, the person
said, declining to be identified because the inquiry isn’t
public.
Bloomberg News reported last week that Jobs is considering
a liver transplant as a result of complications Read the rest of this entry »
Tags: about, Apple, Disclosures, FACE, Health, jobs, Review, said Posted in Health, News | No Comments »
UPPSALA, Sweden, Jan. 14, 2009 (GLOBE NEWSWIRE) — Oasmia has been granted Expedited Review Status (ERS) for the company’s Animal Health product candidate. The company also changes the name of the candidate from Paclical(r) Vet to Paccal(r) Vet in order to use the same name world-wide.
The center for Veterinary Medicine, Food and Drug Administration in the United States has granted to Oasmia Pharmaceutical, Uppsala, Sweden, the product Paclical(r) Read the rest of this entry »
Tags: Expedited, grants, Oasmia, Pharmaceutical, Review, status Posted in Health, News | No Comments »
Health organisations have welcomed the warts and all view of the health system offered by the National Health and Hospitals Reform Commission’s (NHHRC) interim report.
The peak body representing the nation’s public hospitals, area health services and public aged care providers, says the report, released in Canberra on Monday, has revealed years of underfunding.
Australian Healthcare and Hospitals Association (AHHA) executive director Prue Power Read the rest of this entry »
Tags: Groups, Health, Review, system, Welcome Posted in Health, News | No Comments »
June 3, 2009
EXTON, Pa.
,
Feb. 3
ViroPharma Incorporated (Nasdaq: VPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Cinryze C1 Inhibitor (human) as a treatment for acute attacks of Hereditary Angioedema (HAE). The supplemental Biologics License Application (sBLA), submitted to the FDA on
December 1, 2008
, was based on a re-analysis and resubmission of data from a pivotal Phase 3 acute Read the rest of this entry »
Tags: Biologics, grants, License, Priority, Review, Supplemental Posted in Uncategorized | No Comments »
* Shares fall as much as 8 pct
(Recasts, adds analyst comments, updates share movement)
BANGALORE, Feb 23 (Reuters) – Spectrum Pharmaceuticals Inc
(
SPPI.O
) said U.S. regulators have extended the review date of
its experimental cancer drug, Zevalin, by three months to July
2.
The decision by the U.S. Food and Drug Administration comes
after the regulator received a major amendment to an
application for the additional use of Zevalin as first Read the rest of this entry »
Tags: cancer, Date, Drug, extends, Review, says, Spectrum Posted in Uncategorized | No Comments »
Throughout the 1970’s and 1980’s we had “aerobics”. One word for one thing, high impact, freestyle aerobic dance ala Jane Fonda. I hate to admit it, but I was there! I started teaching in the early 1980’s. It was all high impact and as an instructor, we taught “freestyle”. We had our little group of moves, but we just made it up as we went along. After the 30 or so minutes of cardio, we would do 30 minutes of calisthenics for toning. Unfortunately, Read the rest of this entry »
Tags: 2009, Fitness, group, Review, Trends, what Posted in Health | No Comments »
(RTTNews) -
Savient Pharmaceuticals, Inc. (SVNT:
) Thursday said that the US Food and Drug administration has extended the review period of the company’s gout drug by three months to July 30, 2009, following the submission of a major amendment to the previously submitted Biologics License Application, which was granted priority review. Following the news, Savient shares plunged more than 25%, in after-hour trading, Read the rest of this entry »
Tags: Drug, extends, Gout, Period, plunge, Review, Savient, shares Posted in News | No Comments »