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Optune Lua® from Novocure has received approval in Japan for treating unresectable advanced/recurrent Non-Small Cell Lung Cancer (NSCLC)

Novocure announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors for the treatment of adult patients with unresectable advanced/recurrent non-small cell lung cancer...

At World Sleep 2025, Avadel Pharmaceuticals will present new data on LUMRYZ™ (sodium oxybate) for extended-release oral suspension

Avadel Pharmaceuticals plc a biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16...

CorrectSequence Therapeutics' CS-101 Achieves Promising Results in First Patient: High-Precision Base Editing Clinical Treatment for Sickle Cell Disease

CorrectSequence Therapeutics Co., Ltd. (Correctseq), a clinical-stage biotechnology company pioneering transformer Base Editing (tBE) technology for the treatment of severe diseases, today announced the successful treatment of the first sickle...

Theravance Biopharma completes enrollment in Phase 3 CYPRESS study of Ampreloxetine for neurogenic orthostatic hypotension

Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and...

Spruce Biosciences Reports Long-Term Data Showing Efficacy and Safety of Tralesinidase Alfa in Sanfilippo Syndrome Type B

Spruce Biosciences, Inc. a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, announced results from a long-term data integration of...

Jazz Pharmaceuticals announces the U.S. FDA approval of Modeyso™ (dordaviprone) as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma...

Roche's first respiratory test, powered by TAGS technology, has received FDA clearance for SARS-CoV-2, Influenza A, Influenza B, and RSV

Roche announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed...

Klotho Neurosciences, Inc. Partners with AAVnerGene Inc. to Make Gene Therapy Assets of Klotho Available

Klotho Neurosciences, Inc. announced that it is partnering with AAVnerGene Inc. (AAVnerGene), a Rockville, MD-based innovation-driven biotech renowned for its transformative technologies in AAV manufacturing and tissue-targeted delivery. Dr....

Neurocrine Biosciences Presents New Post-Hoc Data from the KINECT®-HD Study, Demonstrating a Significant Reduction in Disease Burden with INGREZZA® (valbenazine) Capsules for Huntington's Disease Chorea

Neurocrine Biosciences, Inc. announced new patient-reported post-hoc data from the KINECT®-HD study highlighting significant reductions in both cognitive and motor-related burdens among adults treated for Huntington's disease chorea with...

Innovent Announces Approval from China's NMPA for Mazdutide, the First Dual GCG/GLP-1 Receptor Agonist, for Chronic Weight Management

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major...

To Target the Multi-Billion Dollar Kidney Disease Market, Mezzion Expands Its Udenafil Pipeline to ADPKD

Mezzion Pharma Co., Ltd. (Mezzion), a leader in rare disease therapeutics, announced the expansion of its udenafil pipeline with the initiation of a pre-clinical study for Autosomal Dominant Polycystic Kidney Disease (ADPKD). This initiative...

The iPSCore™ platform, developed by iXCells Biotechnologies, enables the generation of highly characterized iPSC-derived human cell models

iXCells Biotechnologies USA, Inc. (“iXCells”), a leading cell technology company specializing in the generation of predictive human disease models is pleased to announce the launch of its modular iPSCore™ platform. iXCells’ mission is to empower...

Avanzanite forms a Pan-European partnership with Agios to introduce PYRUKYND® for rare blood disorders

Avanzanite Bioscience B.V. (“Avanzanite”), a fast-growing commercial-stage specialty pharmaceutical company dedicated to bringing rare disease medicines to patients across Europe, announced an exclusive agreement with Agios Pharmaceuticals Inc. A...

Emulate introduces the AVA™ Emulation System, a groundbreaking high-throughput organ-chip platform designed to accelerate drug development

Emulate, Inc., the world leader in Organ-on-a-Chip technology, today announced the commercial launch of the AVA™ Emulation System, a self-contained instrument that cultures, incubates, and images up to 96 independent Organ-Chip samples in a single...

Elysium Therapeutics to Discuss Fentanyl Rebound and Synthetic Opioid Rescue Drug

Elysium Therapeutics, an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral opioids, including synthetic opioids like fentanyl, today announced its participation. "A major...

INBRAIN Neuroelectronics has been awarded a €4 million grant from Spain’s PERTE Chip Program to advance graphene-based brain-computer interfaces

INBRAIN Neuroelectronics, a clinical-stage neurotechnology company developing precision brain-computer interfaces (BCIs) powered by graphene, announced it has been awarded a €4 million grant by the Spanish Ministry of Industry and Tourism through...

SK Life Science Labs Announces Nature Communications Publication of Breakthrough Molecular Glue Research Advancing Cancer Immunotherapy

SK Life Science Labs, a subsidiary of SK Biopharmaceuticals Co., Ltd., a global biotech focused on the research, development, and commercialization of treatments for cancer and disorders of the central nervous system (CNS), announced the...

Innorna Announces FDA Grants Rare Pediatric Disease and Orphan Drug Designations to IN013 for Wilson Disease Treatment

Innorna, a clinical-stage biotechnology company revolutionizing mRNA therapeutics with its innovative lipid nanoparticle (LNP) delivery technology, today announced the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease...

Optune Lua® by Novocure Receives CE Mark Approval for Treating Metastatic Non-Small Cell Lung Cancer

Novocure announced that Optune Lua® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have...

AI Utilized by TNF Pharmaceuticals and Renova Health to Accelerate Drug Development

TNF Pharmaceuticals, Inc. a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, and Renova Health announce the application of AI and machine learning technologies to identify...

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