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The opinion will be subject to review by the EC, which finally grants the decision on orphan drug designation. ATTR-Amyloidosis or TTR amyloidosis is a severe and rare

EGPA, which can be life-threatening for some patients, is previously known as Churg-Strauss syndrome and it is a rare disease which is characterized by widespread inflammation in the

Q203 is being developed for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis and is the first drug in its class with an original mechanism of action. Under the

Compared to other molecules currently in development in the immune therapy cancer space, AUNP-12 provides a breakthrough mechanism of action in the PD-1 pathway. AUNP-12 is the only

Synribo, an oncology portfolio product, was originally granted an accelerated approval by the FDA in October 2012. Additional clinical trial data was required to fulfill post marketing requirements

Abilify Maintena will be the first commercialized product in Canada from the global Otsuka- Lundbeck alliance, which is focused on developing Central Nervous System (CNS) therapies worldwide. The

The launch will feature three products: Rabecure Pack 400 and Rabecure Pack 800, which package together individual blister sheets each containing a daily triple formulation dose of Pariet,

This synovial analysis, suggested by the FDA, tests the change in expression of signaling and structural proteins that arise from the treatment of the knee with either Ampion

The results of Study 801 from the Phase III clinical study demonstrate that extended-release hydrocodone was well tolerated and effective for the treatment of moderate-to-severe chronic low back