News tagged with drug approval
Scientist urges government ruling on genetically engineered salmon
A Purdue University scientist is urging federal officials to decide whether genetically engineered salmon would be allowed for U.S. consumption and arguing that not doing so may set back scientific efforts to increase food ...
Aug 06, 2011 |
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Bill revision could mean money for NJ drug company
(AP) -- A billion-dollar "technical revision" added to a patent bill passed by the House last week could provide huge financial benefits to one pharmaceutical company and a law firm.
Jun 30, 2011 |
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US approves cell therapy injection for wrinkles
US regulators have approved a new type of therapy that uses a person's own skin cells to create an injectable cosmetic plumper to smooth out laugh lines, Fibrocell Science said Wednesday.
Jun 22, 2011 |
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US approves second new hepatitis C drug
The US Food and Drug Administration on Monday approved Incivek to treat hepatitis C when taken along with the current two-drug regimen, marking the second such drug approval this month.
Medicine & Health / Medications
May 23, 2011 |
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US takes aim at purported sex disease 'cures'
The US government said Tuesday it is taking steps to remove from the market a host of online products that promise to cure HIV, herpes, chlamydia and other sexually transmitted diseases.
Medicine & Health / Medications
May 03, 2011 |
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FDA considers new rules to speed up confirmatory trials of drugs granted accelerated approval
Since 1992, the U.S. Food and Drug Administration has granted accelerated approval to 47 new indications for 35 cancer drugs and in more than half the cases—26 indications—further trials have confirmed the benefits ...
Medicine & Health / Medications
Mar 25, 2011 |
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Women get short shrift in many heart device studies, despite requirement
Despite a long-standing requirement for medical device makers to include women in studies they submit to the Food and Drug Administration for device approval, only a few include enough women or analyze how the devices work ...
Mar 01, 2011 |
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Most medical devices recalled because of serious risks did not undergo clinical trials
Most medical devices recently recalled by the Food and Drug Administration because of very serious risks were initially approved through an expedited process or were exempt from regulatory review, according to a report posted ...
Medicine & Health / Medications
Feb 14, 2011 |
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Speedy generic approval may not benefit consumers as much as expected, model shows
Faster approval times for generic drugs will get them into consumers' hands quicker, but may not make the price any better, a pricing and marketing researcher has found.
Medicine & Health / Medications
Feb 08, 2011 |
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FDA: Agency must review tobacco products
(AP) -- The Food and Drug Administration says it must review tobacco products that were introduced or changed over the last four years in order for companies to keep selling them.
Jan 05, 2011 |
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FDA poised to recall unproven blood pressure drug
(AP) -- Federal health regulators are pushing to withdraw a blood pressure drug that has been on the market for 14 years in spite of the manufacturer's failure to submit evidence that it actually helps patients.
Medicine & Health / Medications
Aug 16, 2010 |
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Grandfathered drug for high potassium has no proven benefit
For more than half a century, products containing ion exchange resins have been used in patients with dangerously high levels of potassium. However, there is no convincing evidence that these products are actually effective, ...
Medicine & Health / Medications
Mar 09, 2010 |
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FDA drug approvals mostly flat in 2009
(AP) -- Drug approvals from the Food and Drug Administration were flat last year compared with 2008 and warnings fell, even as the agency's new leadership struck a tougher stance on safety.
Medicine & Health / Medications
Jan 05, 2010 |
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Findings suggest cardiovascular devices often approved by FDA without high-quality studies
Pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a study in the December 23/30 issue of JAMA. The researchers found ...
Dec 29, 2009 |
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New hope on finding better blood thinners
Warfarin, one of the most inconvenient, dangerous and disliked drugs in the world, has remained vitally important for more than 50 years.
Medicine & Health / Medical research
Oct 26, 2009 |
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