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Gilead’s Livdelzi® Shows Sustained Efficacy in PBC, Reducing ALP, Relieving Itch, and Potentially Slowing Disease Progression

Gilead Sciences, Inc. announced new long-term data reinforcing the safety and efficacy profile of Livdelzi® (seladelpar) for people living with primary biliary cholangitis (PBC). Findings support Livdelzi's consistent efficacy and safety outcomes...

PRM Pharma Launches HemiClor® 12.5 mg, the First FDA-Approved Low-Dose Chlorthalidone Tablet for Hypertension

PRM Pharma, LLC announces the nationwide availability of HemiClor® (chlorthalidone) 12.5 mg tablets, the first and only FDA-approved 12.5 mg formulation of chlorthalidone for the treatment of hypertension in adults. This milestone comes as the...

Fresenius Kabi’s biosimilars Conexxence® and Bomyntra® (denosumab-bnht) receive interchangeable designation from the FDA

Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced that the U.S. Food and Drug Administration (FDA) designated Conexxence®(1) and Bomyntra®(2)...

Real-world data presented at TCT 2025 demonstrates that the EggNest™ Complete Radiation Protection System significantly reduces radiation exposure for the entire cath lab

At the 2025 Transcatheter Cardiovascular Therapeutics® (TCT) Conference, Dr. Jarrod Frizzell of The Christ Hospital (Cincinnati, OH) presented real-world studies¹,² demonstrating that the EggNest™ Complete Radiation Protection System from Egg...

To drive global expansion of digital chemistry and discovery, Chemify raises over $50 million in an oversubscribed Series B round

Chemify, the deep-tech pioneer fusing chemistry, robotics, computation, and Chemputation—Chemify’s purpose-built AI to digitize molecule creation—has raised over $50 million in Series B funding to help accelerate its mission of becoming the global...

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...

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®...

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....

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)...

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...

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...

Nuvation Bio unveils new data on IBTROZI™ (taletrectinib) in advanced ROS1-positive non-small cell lung cancer

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced new and updated results from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI™ (taletrectinib) for...

Eisai submitted a rolling sBLA to the U.S. FDA for LEQEMBI® IQLIK™ as a subcutaneous starting dose to treat early Alzheimer’s, under Fast Track status

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®)...

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...

2025 Interim Results and Business Updates Announced by Innovent

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

Gvoke VialDx™ (glucagon injection) Launched by American Regent

American Regent, Inc.® is pleased to announce the commercial launch and availability of Gvoke VialDx™ (glucagon injection). Gvoke VialDx (glucagon injection) is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic...

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...

Izalontamab Brengitecan Receives FDA Breakthrough Therapy Designation for Advanced EGFR-Mutated NSCLC

SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted. Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for...