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Last updated on April 18, 2014 at 14:59 EDT

Latest US Food and Drug Administration Stories

2013-02-14 16:25:28

VILLEPINTE, France, Feb. 14, 2013 /PRNewswire/ -- Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem® (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The Committee voted 10 to 6 (with one member abstaining) not...

2013-02-13 20:21:47

RALEIGH, N.C., Feb. 13, 2013 /PRNewswire-iReach/ -- Scioderm announced that the US Food and Drug Administration (FDA) has reviewed and allowed the investigational new drug (IND) application for SD-101 to proceed. SD-101 is a topical treatment being developed for the treatment of Epidermolysis Bullosa (EB). The Company plans to initiate a Phase 1 study in the coming months, with initiation of the Phase 2B/3 study in EB patients to occur in the second half of 2013. EB is a rare genetic...

2013-01-22 20:20:59

PALO ALTO, Calif., Jan. 22, 2013 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) announced the completion of an End of Phase 2 meeting with the US Food and Drug Administration (FDA). Preliminary agreement was reached regarding the design of a Phase 3 placebo-controlled randomized registration trial of Telintra (ezatiostat) for the treatment of Low to Intermediate-1 risk myelodysplastic syndrome (MDS), using red-blood-cell transfusion independence as the endpoint. In accordance with the FDA's...

2013-01-11 20:22:11

PALO ALTO, Calif., Jan. 11, 2013 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) was notified today that its product candidate, ezatiostat HCL (Telintra), has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS). Orphan designation grants potential US market exclusivity to a drug for the treatment of a specified condition for a period of seven years following FDA marketing approval. Additional potential...

FDA Orders Lower Doses Of Sleep Aids For Women
2013-01-11 08:08:25

redOrbit Staff & Wire Reports - Your Universe Online The US Food and Drug Administration (FDA) is requiring pharmaceutical companies to lower the recommended doses of popular sleeping pills, due to the potential risk of injury resulting from morning drowsiness associated with the medications in recent studies. According to Reuters, studies have demonstrated that pills containing the prescription drug zolpidem (which include products sold under the brand names Ambien, Edluar,...

2013-01-02 16:22:49

Amazon tree-derived medicine cleared for usage in HIV patients with diarrhea AUSTIN, Texas, Jan. 2, 2013 /PRNewswire-USNewswire/ -- The following is being released by the American Botanical Council: (Logo: http://photos.prnewswire.com/prnh/20100430/DC95601LOGO) On New Year's Eve of 2012, the US Food and Drug Administration (FDA) announced its approval of crofelemer (Fulyzaq(TM), Salix Pharmaceuticals, Ltd., Raleigh, North Carolina) -- marking the second time a botanical, and the first...

2012-12-18 08:27:34

NEW YORK, Dec. 18, 2012 /PRNewswire/ -- Transparency Life Sciences, LLC (TLS), the world's first drug development company based on open innovation, today announced that its Investigational New Drug Application (IND) to assess lisinopril as an adjunctive therapy for multiple sclerosis (MS) has been cleared by the US Food and Drug Administration (FDA). This clearance is the first for a clinical trial protocol developed with the aid of crowdsourcing, and is among the first to make intensive use...

Federal Regulator Confirms Reports Of 5-Hour Energy Drink Linked To Deaths
2012-11-15 09:50:44

[WATCH VIDEO: Tom Costello Reports On Energy Drink Deaths] Lawrence LeBlond for redOrbit.com - Your Universe Online After receiving numerous reports linking caffeine to deaths, a US federal regulator said new evidence is pointing to a popular energy shot as being a possible candidate for numerous fatalities due to overuse of the stimulant. The US Food and Drug Administration (FDA) confirmed on Wednesday it had received reports that 5-Hour Energy may have been linked to the deaths of...

Patient Illness Risks Noticed At NECC More Than A Decade Ago
2012-11-14 08:50:58

Lawrence LeBlond for redOrbit.com - Your Universe Online As cases of fungal meningitis stemming from tainted steroid injections continue to climb, lawmakers outline the scope of the deadly outbreak that has so far affected more than 438 people and has resulted in 32 deaths, according to CDC data. In investigations of the government´s response to the outbreak, a US House of Representatives panel has found that the US Food and Drug Administration (FDA) had known more than a decade...

Ameridose Issues Recall On Drugs Due To Meningitis Investigation
2012-11-01 17:44:32

Lawrence LeBlond for redOrbit.com - Your Universe Online Ameridose, a sister company to the US compounding facility responsible for a fungal meningitis outbreak that has now killed 28 people in 19 states, announced Wednesday it is invoking a voluntary recall of its products in cooperation with regulators. While the move could potentially ease the mind of many worried their steroidal injections could be contaminated, it is also contributing to a shortfall in the availability of certain...