FDA Warns Exosome Maker for Marketing Outside Its IND
The FDA has warned Kimera Labs that it can’t sell its exosome product for uses outside of its recently secured investigational new drug (IND) application. In a warning letter that was posted to the FDA’s website last September, then removed, and then posted again this month, the agency also told the Miramar, Florida-based company that […]
Drug Combination Promising as Pre-Sex Birth Control
A drug combination that uses emergency contraception and a cyclo-oxygenase-2 (COX-2) inhibitor may effectively disrupt ovulation, making it the first potential candidate for on-demand, pericoital oral contraception, according to an exploratory pilot study. Among a group of nine patients, six demonstrated ovulation disruption after taking a combination drug of ulipristal acetate (UA) and meloxicam, reported […]