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New HCPCS Billing Code Enables Medicare Reimbursement for Lasix® ONYU When Furnished Incident to a Physician’s Service

SQ Innovation announced that the Centers for Medicare & Medicaid Services (CMS) has established a new Healthcare Common Procedure Coding System (HCPCS) Level II code, J1946 ("Injection, furosemide (Lasix ONYU), 1 mg"), for its product Lasix® ONYU...

U.S. FDA Approves Ziihera® (zanidatamab-hrii), With or Without Tislelizumab Plus Chemotherapy, for the First-Line Treatment of HER2-Positive Advanced Gastroesophageal Adenocarcinoma

Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive...

European Commission Approves DAYBU® (Trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms Associated with Rett Syndrome in the European Union

Acadia Pharmaceuticals Inc. announced that the European Commission (EC) has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and...

Neurolief Advances Veteran Mental Health and Migraine Care With New VA Contract for Prescription Neuromodulation

Neurolief, a neuroscience-driven medical technology company developing brain neuromodulation therapies for mental health and neurological conditions, is bringing two prescription therapies to U.S. veterans through a new Department of Veterans...

Constance Sabbagh Appointed as General Manager as Avanzanite Expands French Operations

Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today announced its expansion into France, Europe’s second largest economy, and the appointment of Constance Sabbagh...

Ark Biopharmaceutical Granted China Marketing Authorization for Aizhida in ADHD Treatment

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...

Jazz Pharmaceuticals presents new clinical and translational data for Modeyso™ (dordaviprone) in H3 K27M-mutant diffuse midline glioma at SNO 2025

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...

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...

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...

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...

IRBM Expands Functional Genomics Platform for Early Drug Discovery

IRBM, an integrated Contract Research Organization (CRO) specializing in preclinical drug discovery, has established a comprehensive Functional Genomics Platform to support genetic target identification and validation, and generation of...

Preclinical study shows NUZ-001 reduces TDP-43 aggregation in ALS

Neurizon Therapeutics Limited a clinical-stage biotech company advancing treatments for neurodegenerative diseases, is pleased to announce positive results from a preclinical study of its lead candidate, NUZ-001. These innovative studies reveal...

Neurocrine Biosciences Launches INGREZZA® SPRINKLE (valbenazine) Capsules.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced the launch of a new sprinkle formulation of INGREZZA® (valbenazine) capsules, the #1 prescribed vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with...

AusperBio's AHB-137 Receives Breakthrough Therapy Designation for Chronic Hepatitis B Treatment

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. a clinical-stage biotechnology company dedicated to advancing targeted oligonucleotide therapies for achieving functional cure in chronic hepatitis B (CHB) infection, announced that their...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...

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