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ADARx doses first patient in Phase 3 STOP-HAE trial; ADX-324 receives orphan drug designation for hereditary angioedema

ADARx Pharmaceuticals, Inc. (ADARx), a late-stage clinical biotechnology company developing next-generation RNA therapeutics, today announced that the first patient has been dosed in its Phase 3 STOP-HAE clinical trial evaluating ADX-324 in...

CTIBIOTECH™ Partners with SATT AxLR and CILCARE to Develop Inner Ear Organoids for Hearing Disorder Screening

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...

Alamar Biosciences Launches NULISAqpcr™ BD-pTau217 Assay: A Breakthrough in Non-Invasive Alzheimer’s Biomarker Detection

Alamar Biosciences, a company powering precision proteomics to enable the earliest detection of disease, announced the launch of the NULISAqpcr™ BD-pTau217 Assay— a transformative leap in blood-based quantification of brain-derived phosphorylated...

FDA Approves ZOLL’s Zenix Monitor/Defibrillator, Elevating Asahi Kasei’s Critical Care Solutions

Asahi Kasei, a global provider of healthcare technology and pharmaceutical solutions, has advanced its suite of critical care products through premarket approval by the U.S. Food and Drug Administration (FDA) for ZOLL’s Zenix®...

Dr. Zivjena Vucetic Appointed as Chief Medical Officer at Mission Bio to Lead Biopharma Partnerships and Clinical Adoption

Mission Bio, a leader in single-cell multi-omics for precision medicine, announced the appointment of Zivjena Vucetic, M.D., Ph.D., as Chief Medical Officer. A physician-scientist with more than 15 years of experience in diagnostics and emerging...

Therapeutics Complement Receives FDA IND Clearance to Advance CTx001 into Opti-GAIN, a Phase I/II Clinical Trial in Geographic Atrophy Secondary to AMD

Complement Therapeutics GmbH (CTx), a biotechnology company developing next-generation therapeutics for complement-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND)...

Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ Subcutaneous Maintenance Dose for Early Alzheimer's Treatment

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM) is now available in the...

Niagen Bioscience's Pharmaceutical-Grade Niagen™ IV and Injections Are Now Available at Over 50 iCRYO Clinics and More Than 900 Clinics Nationwide

Niagen Bioscience, Inc. the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, announces that pharmaceutical-grade Niagen Plus™ products, Niagen IV and injections, are now offered at more...

Novartis Receives FDA Approval for Rhapsido® (remibrutinib), the First Oral, Targeted BTKi Treatment for Chronic Spontaneous Urticaria (CSU

Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment....

Corstasis Therapeutics and U.S. Heart and Vascular® will collaborate to improve heart failure care with ENBUMYST™ (Bumetanide Nasal Spray

Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, announced a strategic collaboration with U.S. Heart and Vascular® (USHV),...

Leqembi® has received approval for intravenous maintenance treatment in China

BioArctic AB's partner Eisai announced that lecanemab (Leqembi) has been approved for once every four weeks intravenous (IV) maintenance dosing for the treatment of early Alzheimer's disease by the National Medical Products Administration (NMPA)...

At the Heart Failure Society of America, Bayer will showcase new data for KERENDIA® (finerenone)

Bayer announced that data from across the KERENDIA® (finerenone) comprehensive clinical trial program will be presented at the Heart Failure Society of America (HFSA)’s. In July 2025, the U.S. Food and Drug Administration (FDA) approved a new...

European Commission Approves Alteogen’s Aflibercept Biosimilar, EYLUXVI® (ALT-L9)

Alteogen Inc. announced today that the European Commission (EC) has granted marketing authorization for EYLUXVI® (code name: ALT-L9), an Eylea® biosimilar co-developed by its subsidiary, Alteogen Biologics. EYLUXVI® is Alteogen's second approved...

Sanguine Expands Oncology Biospecimen Portfolio via Strategic Clinic Partnerships

Sanguine Biosciences, a leading provider of healthy and disease-state human biospecimens and data for research, today announced the expansion of its oncology sample offerings through new partnerships with oncology clinics nationwide. These...

LOTUS study data on DAYBUE® (trofinetide) for Rett Syndrome's long-term efficacy and tolerability is published in Developmental Medicine and Child Neurology

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...

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 the American Thyroid Association meeting, FORE Biotherapeutics presented Phase 1/2a data for Plixorafenib, demonstrating a prolonged duration of effect in BRAF-altered thyroid cancers

FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today presented new plixorafenib results from the previously completed Phase 1/2a clinical trial that...

At the PHPN 2025 Symposium, Corsair Pharma will present new data on its proprietary transdermal system for Treprostinil prodrug

Corsair Pharma, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative transdermal therapies for pulmonary arterial hypertension (PAH), today announced it will present new data on the TRX-248 Transdermal System at the...

Medicines Discovery Catapult and Crown Bioscience form a global alliance for radiopharmaceutical innovation

Medicines Discovery Catapult (MDC) and Crown Bioscience have formed a strategic global collaboration to deliver an integrated translational biology platform for innovators developing radiopharmaceuticals. Radiopharmaceuticals are a growing class...

Marius Pharmaceuticals and Hims & Hers™ collaborate to expand access to KYZATREX® (testosterone undecanoate) CIII capsules, the first FDA-approved oral testosterone therapy available on the Hims & Hers platform

Marius Pharmaceuticals, Inc. announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone...