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  • FDA OK's drug to treat high ammonia levels (19 Mar 2010 04:57)

    ... FDA OK's drug to treat high ammonia levels ... high ammonia levels Washington -- The U.S. Food and Drug Administration says it has approved Carbaglu tablets to treat a condition that ...

  • FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia (19 Mar 2010 06:17)

    ... Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor The introduction of Silenor, a sleep promoting ...

  • A.P. Pharma Receives FDA Complete Response Letter for APF530 (19 Mar 2010 11:50)

    ... a Complete Response Letter from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application ... Injections and oral tablets containing granisetron are approved for the prevention of acute onset CINV, ...

  • UPDATE: FDA Panel Backs Wider Use Of Boston Scientific CRT Defibrillators (19 Mar 2010 00:19)

    ... defibrillator sales halt.) WASHINGTON -(Dow Jones)- A Food and Drug Administration panel Thursday unanimously backed broader use of ... mild-to-moderate heart failure. The devices are currently approved for use in patients with more severe ... some manufacturing process changes weren't submitted for FDA approval as required. Kenneth Stein, Boston Scientific's ...

  • Recordati : Carbaglu Approved By the FDA For Use In the US" class="newsHeadline">Recordati : Carbaglu Approved By the FDA For Use In the US (19 Mar 2010 14:15)

    ... Recordati : Carbaglu Approved By the FDA For Use In the US MILAN, ITALY ... -- Recordati announces the approval by the Food and Drug Administration (FDA) in the U.S. of the NDA ...

  • FDA approves Recordati's NAGS deficiency drug (19 Mar 2010 12:48)

    ... a rare genetic blood disorder. The US Food and Drug Administration (has approved Carbaglu (carglumic acid) for the treatment of ... normal range within three days. However the FDA insisted that the drug should only be ...

  • Device maker Regen Biologic challenges FDA plan to reassess highly-contested knee implant (19 Mar 2010 15:43)

    ... at the center of a highly controversial Food and Drug Administration approval is pushing back against the agency's ... three contentious years under review at the FDA before gaining approval in 2008. When newly ... in 2005 to request its device be approved under the so-called 510k system. Under the ...

  • FDA approves expanded indication for Boston Scientific's CRT-Ds (19 Mar 2010 09:13)

    ... Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval of an ... Boston Scientific. "If an expanded indication is approved by the FDA, many additional patients would ... would become the only company with an FDA-approved CRT-D for high-risk New York Heart Association ...

  • RECORDATI : CARBAGLU® APPROVED BY THE FDA FOR USE IN THE U.S.A. (19 Mar 2010 08:06)

    ... RECORDATI : CARBAGLU APPROVED BY THE FDA FOR USE IN THE U.S.A. Milan, 19 ... - Recordati announces the approval by the Food and Drug Administration (FDA) in the U.S. of the NDA ...

  • RECORDATI : CARBAGLU(R) APPROVED BY THE FDA FOR USE IN THE U.S.A. (19 Mar 2010 08:07)

    ... APPROVED BY THE FDA FOR USE IN THE U.S.A. MILAN, ITALY--(Marketwire ... - Recordati announces the approval by the Food and Drug Administration (FDA) in the U.S. of the NDA ...

  • FDA denies approval of AP Pharma nausea drug; shrs sink (19 Mar 2010 13:05)

    ... * FDA expresses concern about drugs administration system * ... ) said U.S. health regulators did not approve its experimental drug for the treatment of ... time needed for a resubmission. The U.S. Food and Drug Administration requested clarification and revision of certain analytical ...

  • A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter (19 Mar 2010 13:29)

    ... a Complete Response Letter from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application ... completed and questions remain that preclude the approval of the NDA in its current form. ...

  • A.P. Pharma Receives FDA Complete Response Letter for APF530 - Company to host conference call at 9:00 a.m. ET on Friday, March 19, 2010 - (19 Mar 2010 12:04)

    ... A.P. Pharma Receives FDA Complete Response Letter for APF530 - Company ... a Complete Response Letter from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug ... completed and questions remain that preclude the approval of the NDA in its current form. ...

  • FDA turns back A.P. Pharma nausea drug (19 Mar 2010 17:57)

    ... tumbled about 44 percent mid-day as the Food and Drug Administration raised questions about the company’s drug for ... oral tablet versions of that drug are approved for prevention of acute onset chemotherapy-induced nausea ... acute and delayed-onset nausea and vomiting. The FDA told A.P. Pharma to perform two studies ...

  • FDA panel backs implant for mild heart failure (19 Mar 2010 00:11)

    ... Thursday an electronic heart implant should be approved for a large group of heart-disease patients ... currently aren't eligible for the device. A Food and Drug Administration panel of cardiologists voted unanimously in favor ... tracks the long-term safety of patients. The FDA is not required to follow the panel's ...

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