The U.S. Food and Drug Administration (FDA) has given approval to start producing ViiV Healthcare’s cabotegavir, the first and only long-acting injectable pre-exposure prophylactic (PrEP) to reduce the risk of sexually acquired HIV-1. HIV-1 affects nearly 38 million...
Biopharmaceutical company, Intra-Cellular Therapies, has announced U.S. Food and Drug Administration (FDA) approval of CAPLYTA to treat bipolar I and bipolar II disorders. Bipolar is a mental disorder characterized by unusual mood swings, energy levels, and...
Chinook Therapeutics announced that their drug, atrasentan, has been granted orphan drug designation by the European Commission for the treatment of primary IgA nephropathy (IgAN). The chronic kidney disease (CKD), IgAN, is the most common primary glomerular disease...
HUYABIO International has announced regulatory approval of Hiyasta® (HBI-8000) monotherapy by the Ministry of Health, Labour and Welfare (MHLW) of Japan for the treatment of relapsed or refractory (R/R) Peripheral T-cell lymphoma (PTCL). This approval is based on...
Takeda Pharmaceutical’s Livtencity (maribavir) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with post-transplant cytomegalovirus (CMV) who have displayed resistance to other common antiviral drugs such as...
The U.S. Food and Drug Administration (FDA) has given clearance to Neurent Medical’s NEUROMARK™ Rhinitis Neurolysis Therapy™ (RNT), a proprietary system which provides physicians access to the first in-office treatment for those suffering from chronic rhinitis....
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