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The specialty pharmaceutical company had submitted a new drug application, seeking approval for Tlando as TRT for adult males with conditions caused by deficiency of endogenous testosterone (hypogonadism). Lipocine

The approval has been granted for Lynparza (olaparib) tablets (300mg twice daily) to be used as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian

For over a decade, fewer than 10% of clinical trials that enter Phase I achieve FDA approval. Too many new drug submissions receive a rejection letter, request for

The label update is effective immediately and based on results from the Phase 4 TOURMALINE study, which showed no statistically significant difference between the groups taking Veltassa with

As per the terms of the deal, the Japanese pharma company will pay $30.33 in cash for each Shire share along with either 0.839 new Takeda shares or

The deal gives Luye the rights to Seroquel and Seroquel XR in the UK, China and other international markets, including Brazil, Australia, Saudi Arabia, Mexico, South Korea, Thailand,

The portfolio primarily consists of oral solutions with a few semi-solid products.  For the 12 months ended March 2018, combined sales of the acquired products were in excess

As a diversified company with a robust generics business, Amneal is now the 5th largest generics business in the United States, with a growing, high-margin specialty franchise. Shares

The US Food and Drug Administration (FDA), which accepted the company’s supplemental Biologics License Application (sBLA), gave the designation for the combination to be used as first-line treatment