FDA Approvals - DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA
DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA Action Date for orBec(R) New Drug Application to Review ... (Marketwire via Yahoo! Finance)
DOR BioPharma, Inc. announced today that it has received notification from the United States Food and Drug Administration that the action date for the FDA's review of the New Drug Application for orBec for the treatment of gastrointestinal graft-versus-host disease has been extended to October 21, 2007. The original action date under the Prescription Drug User Fee Act for the orBec NDA was ...
OUTLOOK Pharming H1 seen as unsurprising, analysts await product updates (Sharewatch)
AMSTERDAM (Thomson Financial) - Pharming Group NV is not expected to announce any qualitative surprises in its earnings for the first half of 2007 today, while investors await updates on the approvals process for the pharmaceutical group's lead product, Rhucin, analysts said.
FDA letter knocks Neurochem shares lower (Reuters via Yahoo! Canada News)
Shares of Neurochem Inc. were down on Wednesday, but well off their session low, with analysts divided on the prospects for the drug maker's Kiacta amyloidosis treatment getting approval in the United States after the Food and Drug Administration requested more trial data.