SQ Innovation, developer of Lasix® ONYU, announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, and the acceptance of Lasix ONYU by the European...
Cellenkos®, Inc., a clinical-stage biotechnology company, developing allogeneic, tissue-targeted regulatory T cell (Treg) therapies, today announced the receipt of U.S. Food and Drug Administration (FDA) clearance to initiate CK0801 Phase 2...
Neurocrine Biosciences, Inc. announced the first presentation of new two-year data from the Phase 3 CAHtalyst® Adult study demonstrating sustained, substantial reductions in glucocorticoid (GC) doses in adults with classic congenital adrenal...
Avantor, Inc. a leading global provider of mission-critical products and services to customers in the life sciences and advanced technology industries, announced the expansion of its North American quality control capabilities with the addition of...
Epia Neuro, a brain computer interface company developing intent-driven systems to restore independence for people living with neurological conditions, announced its official launch. The company is advancing a proprietary neural interface platform...
-Cognito Therapeutics, a late clinical-stage neurotechnology company pioneering non-invasive neuroprotective therapies in neurodegenerative diseases, today announced the final close of its oversubscribed $105 million Series C funding. The round...
Neurizon® Therapeutics Limited a clinical-stage biotechnology company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that the first participant has been dosed in Regimen I of the HEALEY ALS...
Align Technology, Inc. a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative...
Shanghai Ark Biopharmaceutical Co., Ltd. announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application for Serdexmethylphenidate Chloride and Dexmethylphenidate Hydrochloride Capsules (Aizhida) for...
Coya Therapeutics, Inc. a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announced positive results of an investigator-initiated...
Nia Therapeutics announced publication in Brain Stimulation of the first in vivo validation of its Smart Neurostimulation System (SNS), a wireless, implantable brain-computer interface designed for closed-loop treatment of memory disorders. The...
Jazz Pharmaceuticals plc announced that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii. The presentations will feature both clinical and...
Rubedo Life Sciences, Inc. a leading AI-driven, clinical-stage biotech specializing in selective cellular rejuvenation medicines, announced a strategic partnership with SVAX during the Future Investment Initiative (FII) week in Riyadh. This...
CTIBIOTECH™, a leading innovator in human tissue engineering and 3D bioprinting, is proud to announce its selection by SATT AxLR and CILCARE to support the development of the OrgaEar project. This strategic collaboration aims to create a world...
Acadia Pharmaceuticals Inc. announced that the journal Developmental Medicine and Child Neurology published interim results from the caregiver-reported observational online, open-label, ongoing LOTUS study evaluating effectiveness and tolerability...
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...
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, 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 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 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...
