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...
FDA Grants ODD Status to SEL24/MEN1703 for Treatment of AML
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to SEL24/MEN1703, an orally available, dual PIM/FLT3 inhibitor designed for the treatment of Acute Myeloid Leukemia (AML). Licensed by the Menarini group from Ryvu Therapeutics,...
Expanding AI Healthcare Capabilities Driving Global Growth
Considering estimations predict that AI in the global healthcare market will reach $194.4 billion by 2030, it is clear that AI (artificial intelligence) is an increasingly crucial tool for the future of healthcare. CSOFT has written extensively on AI in our AI...
HPV Vaccinations: UK Cervical Cancer Program Shows Success
The results of an England-based national program to vaccinate females against human papillomavirus (HPV) to protect against cervical cancer has shown significant success, new data from England shows. Among this success is a reported 87% decrease in cervical cancer...
FDA Grants Memgen IND Application Clearance
The US FDA (Food and Drug Administration) has granted IND (investigational new drug) application clearance for Memgen’s MEM-288, their cancer immunotherapy treatment for patients with multiple solid tumors. Following this announcement, Memgen, a clinical-stage...
Eli Lilly Retracts From EU, While US Buys Antibody Doses
While Eli Lilly has withdrawn its request for European Union (EU) approval of its COVID-19 antibody-based treatment as the EU pivots its focus on other suppliers, the US has agreed to buy 614,000 additional doses of Lilly's antibody combo for $1.29 billion. The...
Positive Data for Aquestive Therapeutics Sublingual Film
Aquestive Therapeutics, (previously MonoSolRX), known for specializing in the development and commercialization of products that meet unmet needs for patients, has announced positive topline data from its first-in-human Phase 1 PK study of AQST-109 sublingual film for...
Breast Implants: FDA Issues Stronger Risk Warning Labels
The US FDA (Food and Drug Administration) has announced new labels for boxed warnings, to further warn and inform consumer decision-making when considering the risks around breast implants. Included in this announcement, the FDA will also be limiting the sale and...