TherapeuticsMD (NSDQ:TXMD) said today that it won FDA approval for its applicator-free estradiol vaginal capsule, TX-004HR. The soft-gel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause. Get the full story at our sister site, Drug Delivery Business News.
TherapeuticsMD
TherapeuticsMD negotiates label for vaginal capsule after NDA resubmission
TherapeuticsMD (NSDQ:TXMD) is negotiating with the FDA over the proposed label for its investigational, applicator-free estradiol vaginal capsule, TX-004HR, the company reported today. The softgel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause. Get the full story at our sister […]
TherapeuticsMD submits NDA for hormone therapy to treat vasomotor symptoms
TherapeuticsMD (NSDQ:TXMD) has submitted its bio-identical hormone therapy to the FDA for approval as a treatment for moderate-to-severe vasomotor symptoms due to menopause. The company’s investigational combination of estradiol and progesterone is delivered in a single, oral soft-gel capsule. Get the full story at our sister site, Drug Delivery Business News.
TherapeuticsMD shares tumble after FDA pushes NDA decision to mid ’18
TherapeuticsMD (NSDQ:TXMD) shares fell -7% yesterday after the company announced that the FDA accepted its resubmitted application for TX-004HR, an investigational, applicator-free estradiol vaginal soft-gel capsule for the treatment of dyspareunia. The company’s shares took a hit presumably because it revealed that its resubmitted application is a Class 2 response – a Class 1 response would […]
Sancilio withdraws $86m IPO for lipid-based drug delivery
Sancilio Pharmaceuticals last week withdrew its plans for an initial public offering it hoped would bring in $86 million for its Advanced Lipid Technology drug delivery platform. The Florida-based company registered the IPO in August 2015, but today requested that the SEC consent to its withdrawal, without giving a specific reason. The company’s drug delivery […]