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Immtech has initiated, in partnership with the University of North Carolina at Chapel Hill, a Phase III trial of its oral drug DB289 in the Democratic Republic of Congo to treat Trypanosomiasis (African sleeping sickness).
Join FDAnews Tuesday, Aug. 30, for a 90-minute audioconference on "Preparing
for an FDA Preapproval Inspection." Learn from FDA veteran David Barr
how to prepare for and manage these inspections to avoid misunderstandings,
prevent delays in the approval process, and eliminate unnecessary costs. On
Aug. 31, join FDAnews for "Step-By-Step Guide to Clinical Trials:
Effectively Execute a Study From Design to Audit." Gather your team together
to learn from expert William Sietsema, Ph.D., as he guides you step by
step on the best ways to execute a clinical trial -- from how to engineer
a clinical program and organize a project team to what to do if your site is
audited by the FDA.
Vicuron Pharmaceuticals has filed a new drug application (NDA) with the FDA for anidulafungin for the treatment of invasive candidiasis/candidemia, the most common hospital-acquired fungal infection.
Neurochem has initiated the submission of a "rolling" new drug application (NDA) to the FDA seeking marketing approval for its investigational product candidate, Fibrillex, for the treatment of Amyloid A (AA) Amyloidosis.
Solvay Pharmaceuticals and CV Therapeutics have announced that the FDA has approved Aceon (perindopril erbumine) tablets for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction (MI).
Protez Pharmaceuticals intends to accelerate development of its lead compound SMP-601, a potent injectable antibiotic with a uniquely broad spectrum of activity against both drug resistant gram-positive and many gram negative-pathogens.