Bayer admits withholding drug study from FDA
Bayer has said that it mistakenly did not inform the FDA about a retrospective study commissioned by the company to analyze the effects of Trasylol in patients undergoing
Bayer has said that it mistakenly did not inform the FDA about a retrospective study commissioned by the company to analyze the effects of Trasylol in patients undergoing
“The US market for therapies for the eradication of helicobacter pylori is in excess of $160 million, and because of under diagnosis there is significant growth potential for
Avelox is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat cIAI, and has been shown to be effective at eradicating the most common
The agreement provides Amgen with Avidia's lead product candidate, an inhibitor of interleukin 6 (IL-6) for the treatment of inflammation and autoimmune diseases, which is in phase I
The Indianapolis-based drug maker said that it was “weighing options” relating to ruboxistaurin mesylate (proposed brand name Arxxant). The FDA said it wants additional efficacy data before it
Dengue fever is the second most widespread tropical disease after malaria. Dengue fever is a mosquito-borne disease affecting up to 100 million people every year, primarily children, resulting
MK-0524B is a combination of MK-0524A and Zocor (simvastatin) which would provide the proven cardiovascular benefits of two widely recognized agents in a single tablet. MK-0524A is an
The research was undertaken as a result of concerns raised by the FDA that the nasal spray could cause allergic reactions. The review by the FDA said allergic
In this study, patients with FSAD using Alista achieved a more than doubling over baseline in the number of satisfactory sexual events; however, the difference between the Alista
In August, Corcept said that the first of its trials for Corlux had failed. Corlux is Corcept’s lead product in development. The primary endpoint of the study was