VBI Vaccines’ drug candidate PreHevbrio, developed to prevent infection among patients diagnosed with the hepatitis B virus, has been approved by the U.S. Food and Drug Administration (FDA). Affecting around 296 million people worldwide, chronic hepa-B infection is a...
SIGA Technologies Inc. has announced that Health Canada has approved its oral, small-molecule drug TPOXX (tecovirimat) as an extraordinary use drug for patients with human smallpox disease. Though eradicated in 1980, smallpox remains a contagious and potentially...
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....
Pfizer has announced that it has reached a licensing agreement with the Medicines Patent Pool (MPP), an UN-backed public health organization, enabling them to sign agreements with multiple manufacturers that will allow them to supply over half the world’s population...
The Saudi Food and Drug Authority (SFDA) has granted approval to BRUKINSA (zanubrutinib), a joint venture by BeiGene and NewBridge Pharmaceuticals, for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received a prior therapy. Upon...
For patients suffering from either of the predominant variations of ANCA-associated vasculitis, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has...
The U.S. Food and Drug Administration (FDA) has cleared Vektor Medical’s vMap system, a groundbreaking system that when paired with standard ECG practice, has the ability to construct a model of the patient’s heart electrophysiological activity using input from only a...
The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to Zandelisib, a drug produced in collaboration between MEI Pharma and Kyowa Kirin Inc for the treatment of follicular lymphoma (FL). Developed as a once-daily, oral investigational...
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