The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to aficamten, a cardiac myosin inhibitor, for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Hypertrophic cardiomyopathy (HCM) is a condition...
The U.S. Food and Drug Administration (FDA) has approved Saol Therapeutics’ LYVISPAH (baclofen) oral granules for the treatment of spasticity, flexor spasms, concomitant pain, and muscular rigidity resulting from multiple sclerosis (MS). LYVISPAH, as opposed to...
The China National Medical Products Administration (NMPA) has approved SYLVANT (siltuximab for injection) for the treatment of patients with multicentric Castleman disease (MCD), BeiGene Ltd. and EUSA Pharma Ltd today announced. MCD is known as a lymphoproliferative...
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...
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