Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.

FDA Approves Bionovo's Clinical Development Plan for Menerba Key FDA Clinical Meeting Held; Company on Track to Initiate Phase 3 Trials for Menerba EMERYVILLE, Calif., Nov. 10, 2010.

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Menerba's Phase 2 clinical trial indicated it is well tolerated with no serious side effects and statistically superior to placebo in reducing the number of hot flashes in menopausal women.

The FDA has indicated its agreement with Bionovo's Chemistry, Manufacturing and Controls (CMC) plan for menopausal hot-flash treatment Menerba. The oral candidate, an estrogen receptor beta (ER-b) ...

Bionovo Inc <BNVI.O> said the U.S. Food and Drug Administration approved the clinical development plan for its lead drug candidate, Menerba, for treating hot flashes related to menopause, sending ...

Sept 23 (Reuters) - Bionovo Inc <BNVID.O> said U.S. health regulators accepted the chemistry, manufacturing and controls plan for its lead drug candidate, Menerba, an experimental treatment for ...