NKX101: FDA Orphan Drug Designation for Nkarta’s AML Drug
In a potential development for clinical trial translations to come, the U.S. Food and Drug Administration (FDA) authorized orphan drug designation (ODD) to Nkarta’s engineered natural killer (NK) cell therapy NKX101 for the treatment of acute myeloid leukemia (AML)....
Nuvation Bio: FDA Fast Track Designation for NUV-422 Drug
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NUV-422, a cyclin-dependent kinase (CDK) inhibitor developed by Nuvation Bio. NUV-422 was developed for the treatment of patients with high-grade gliomas, aggressive tumors that can be...
Chinook Therapeutics: Orphan Drug Designation for IgAN
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...
Natrunix: FDA Approves XBiotech’s IND Therapy
The US Food and Drug Administration’s (FDA) Division of Rheumatology has authorized the clinical development of XBiotech's Investigational New Drug (IND) Natrunix, a candidate antibody therapy to treat rheumatological diseases. Rheumatological disease, a condition...
FDA Approves Thermo Fisher’s CDx Cancer Tissue Test
The U.S. Food and Drug Administration (FDA) has granted premarket approval for Thermo Fisher's Oncomine Dx Target Test as a companion diagnostic (CDx) developed to help identify non-small cell lung cancer (NSCLC) patients. Lung cancer is the leading cause of cancer...
Aficamten Granted Breakthrough Designation for HCM treatment
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...
FDA Approves Saol Therapeutics’ LYVISPAH for MS Spasticity
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...
SYLVANT: BeiGene and EUSA Pharma Drug Gains NMPA Approval
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’ PreHevbrio Approved to Prevent HBV
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...
TPOXX: SIGA Technologies Drug Approved for Extraordinary Use
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’s Hiyasta (HBI-8000) Approved to Treat R/R PTCL
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...
Livtencity Approved for Treatment of Post-Transplant CMV
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...
NEUROMARK™ Granted FDA Clearance to Combat Chronic Rhinitis
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/MPP Agreement Establishes Global Supply of Treatment
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...
SDFA Approves BRUKINSA for Adults with Mantle Cell Lymphoma
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...
CHMP Recommends Avacopan for Treatment of GPA/MPA Vasculitis
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...
vMap: Vektor Medical’s Heart Map System Gains FDA Clearance
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...
MEI Pharma and Kyowa Kirin’s Zandelisib Given ODD Status
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...
Plus Therapeutic’s Rhenium-186 Gains Fast Track Designation
The U.S. Food and Drug Administration (FDA) has given Plus Therapeutics Inc. a Fast Track Designation for Rhenium-186 NanoLiposome (186 RNL), a novel drug for the treatment of leptomeningeal metastases (LM). As a rare complication of cancer, LM primarily occurs with...
Pops Self-Care Platform Gains Australian Clearance
The Therapeutic Goods Administration, Australia’s regulatory body, has given clearance to Pops, a digital health company dedicated to addressing chronic conditions including diabetes. Pops, which has already been commercialized in the United States, gained prominence...