TherapeuticsMD flags “deficiencies” in NDA; CRUK, NCI collaborate on RAS inhibitor research
→ Boca Raton, FL-based TherapeuticsMD $TXMD is flagging some serious problems for their new drug application at the FDA. In a statement today the company said regulators had identified “deficiencies” in their application, though it’s not exactly sure what those deficiencies are. They’re seeking a marketing approval for TX-004HR, “an investigational bio-identical 17β-estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.” The biotech says it plans to find out what the deficiencies are and resolve them ASAP.
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