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News Topic - FDA

RSS feedDisplaying articles 1 - 10 of most recent articles

Sarepta CEO Ousted; New Boss Promises Renewed Focus On FDA Approval Chris Garabedian, the chief executive who turned Cambridge, Mass.-based Sarepta Therapeutics from a floundering antiviral company called AVI Biopharma into an investor darling, resigned today, according to a press release from the company. Garabedian&rsqu | 5 hours, 25 minutes ago | comment? | recommend
FDA approves study to test SynCardia's smaller artificial heart The U.S. Food and Drug Administration approved an investigational study of SynCardia Systems Inc.'s smaller total artificial heart. The 50cc heart is the smaller version of the 70cc SynCardia Heart, which is approved by regulatory agencies in the U.S., Ca | 6 hours ago | comment? | recommend
Dyax shares jump on drug study, FDA fast-track status SAN FRANCISCO (MarketWatch) -- Shares of Dyax Corp. jumped in the extended session Tuesday after the biotech reported promising results for its treatment of a rare inflammatory condition. Dyax shares rallied 38% to $23.14 on heavy volume. In an early-stag | 11 hours, 4 minutes ago | comment? | recommend
Why we should care that an FDA panelist forgot to disclose conflicts of interest The news that a participant at a recent Food and Drug Administration panel failed to disclose his financial conflicts of interest ahead of time has raised a slew of question over the past 24 hours. One of those is: Why should people care? A brief synopsis | 13 hours, 25 minutes ago | comment? | recommend article from Boston, Massachusetts
FDA to scrutinize unproven alternative remedies Federal officials plan to review the safety and evidence behind alternative remedies like Zicam and Cold-Eeze, products that are protected by federal law, but not accepted by mainstream medicine.
The Journal Record | 14 hours, 47 minutes ago | comment? | recommend article from Oklahoma City, Oklahoma
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GNC, NY AG Deal: Herbal Supplements Were In Compliance, But New Testing Requirements Instated A deal reached by GNC and the NY AG's office affirms that the company's products fulfilled FDA requirements, but it will still implement more stringent testing and safeguards | 20 hours ago | comment? | recommend
Five Things You Need to Know: An FDA conflict, Monday mentoring and one heck of a payday at CVS Good morning Boston, its the last day of March! In like a lion, out like a lamb right? As you ponder that one, here are five important news nuggets to help you start your day. FDA panelist concedes conflict of interest Its a credit to the BBJs Don Seiffer | 20 hours, 52 minutes ago | comment? | recommend article from Boston, Massachusetts
Novartis announces FDA approval for Jadenu to simplify treatment administration for patients with chronic iron overload EAST HANOVER, N.J., March 30, 2015 /PRNewswire/ --Novartis announced today that the US Food and Drug Administration (FDA) has approved Jadenu™ (deferasirox) tablets, a new oral formulation of Exjade® (deferasirox) tablets for oral suspens
PR Newswire | Mar 30, 2015 11:03 PM [GMT] | comment? | recommend
Why the FDA wont regulate the Apple Watch to death Back when the Apple Watch was nothing more than a rumor, there was an endless stream of stories focusing on all of the biomedical engineering talent Apple was bringing on board. Consequently, we started to see an influx of reports detailing all of the inc
Yahoo! News | Mar 30, 2015 10:25 PM [GMT] | comment? | recommend
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GNC agrees to new supplement testing procedures GNC has agreed to implement stricter testing procedures for herbal supplements that far exceed FDA requirements.
KWWL TV | Mar 30, 2015 8:30 PM [GMT] | comment? | recommend article from Waterloo, Iowa