News

The proprietary platform centers on the use of a naturally occurring sugar polymer, heparosan, which is produced by the body and is naturally biodegradable. The platform includes a

Titled INSIGHT-MM, the study aims to enroll 5,000 patients over three years with a goal of following each patient for a minimum of five years in an effort

The settlement relates to a patent infringement litigation brought by Forest and Adamas in response to Amneal's abbreviated new drug application (ANDA) seeking approval to market generic versions

Among the changes, the FDA is requiring boxed warnings – the FDA’s strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines

In July, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval. The drug is already approved in Europe to

The PINNACLE study enrolled 145 patients with extensive-stage SCLC who had not received prior treatment.  Topline data from the Phase 2 trial are expected to be reported at

The study, which is the first of two double-blind trials in the FIT Phase 3 clinical program, demonstrated that 18% of patients receiving fostamatinib achieved a stable platelet

These minutes confirmed the FDA’s acceptance of Tonix’s proposed Phase 3 studies and the planned New Drug Application (NDA) data package to support the registration of TNX-102 SL

The study met all primary and secondary endpoints at 12 months. The data showed that treatment with Prolia for 12 months, compared to risedronate, led to significantly greater