Talk about a tough audience! You know the Food and Drug Administration is becoming strict when a drug that’s already approved for one indication can’t
into a second, related indication, especially when its short-acting counterpart is already approved for the indication.
. Last night the health-care giant announced that the FDA has asked for more information before approving its application to market Risperdal Consta for frequently relapsing bipolar Read the rest of this entry »

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Dr. Steven Teitelbaum, a pathology and immunology professor at
, said scientists there were enthused about the prospect of advancing research with embryonic stem cells but also shared a word of caution about expectations.
“We want to see the promise of this therapy move forward,” he said Friday. “But we have to be careful about expectations. This is not a clinical trial to test whether embryonic stem cells will work therapeutically. Read the rest of this entry »

JEFFERSON CITY, Mo. (Legal Newsline)-Pointing to his father’s battle with diabetes, Missouri Attorney General Chris Koster praised the Food and Drug Administration’s decision to allow testing using human embryonic stem cells.
“As the son of a man who battled diabetes, I believe stem cell research is an important channel to fight disease,” Koster said in a statement.
Last week, the FDA gave a green light to Menlo Park, Calif.-based biotechnology Read the rest of this entry »

Doctors will decide on Tuesday whether to operate and separate a pair of newly-born conjoined twins.
Laura Williams, 18, from Shrewsbury, Shropshire, gave birth to the girls, named Faith and Hope, at University College Hospital, London on Friday.
They are joined from their breastbone to their navel, so share a liver but have separate hearts.
Their mother told the Mail on Sunday that her babies, who are now at Great Ormond Street Hospital were Read the rest of this entry »

Blair Wood, Media Wales
WALES have delayed a decision on James Hook’s fitness for Saturday’s crunch test against New Zealand, with assistant coach Shaun Edwards declaring: “He’s 50-50.”
Edwards insisted the mercurial Hook, who picked up a knee injury during Friday night’s 34-13 victory over Canada, would be given as much time as possible to prove his fitness.
But he explained the Ospreys star’s involvement Read the rest of this entry »

Rep. Rosa DeLauro, a frequent critic of the actions of the U.S. Food and Drug Administration, is questioning the agency’s call on the relative safety of
, known as BPA.That’s a compound used in the production of plastics, such as those common in water bottle and baby bottle construction.
DeLauro, who is chairwoman of the House subcommittee that oversees the FDA, reacted today to the release of the latest scientific report that links BPA tonegative Read the rest of this entry »

The provincial government’s recent decision to put the breaks on a plan to hire more nurses is a broken promise a community like Brampton can’t afford.
Last April, Ontario Premier Dalton McGuinty announced the Grits would deliver on a promise to bring 9,000 more nurses to help close a growing gap in Ontario’s health system.
That promise, along with a pledge of 50 more family health teams, has now been put on hold because a fiscal crisis and dwindling Read the rest of this entry »

Rafael Benítez is still to decide whether to gamble on Steven Gerrard’s fitness against Real Madrid despite including the Liverpool captain in the squad for Wednesday night’s Champions League last-16 first leg at the Bernabéu.
The influential midfielder, who has been absent for almost three weeks with a torn hamstring, was named in the traveling party following a personal training session this morning. However, Gerrard is yet to take part in a Read the rest of this entry »

Nov 10, 2008 (financialwire.net via COMTEX) –
— November 10, 2008 (FinancialWire) — The Food and Drug Administration said that it will not make a decision on Discovery Laboratories Inc.’s (NASDAQ:
) respiratory drug Surfaxin until next April at the earliest.
The FDA asked Discovery for more information about its drug Surfaxin in May, and the company responded in September. No new clinical trials were required.
Surfaxin is designed to treat Read the rest of this entry »

) includes an updated FDA calendar of 65 expected decision dates included in the ETF Innovators (ETFI) New Drug Regulatory Catalyst Index, with six companies listed in red with overdue decisions and the possibility for five decisions during the coming week.
for my previous FDA calendar articles. Below is a review of recent decisions + a preview of the coming week’s activity:
1.) Allergan (
) received FDA approval on Friday for Latisse (bimatoprost Read the rest of this entry »