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Takeda's ORZEYFUL™ Receives U.S. FDA Approval for Narcolepsy Type 1

Takeda announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent...

BEACON Real-World Study Shows Positive Top-Line Results for ZUNVEYL® in Alzheimer’s Disease, Reports Alpha Cognition

Alpha Cognition Inc. a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, announced the top-line results from its BEACON real-world study evaluating provider-reported cognitive, behavioral,...

XOCOVA® Becomes First Oral Option for Post-Exposure COVID-19 Prevention

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved XOCOVA® (ensitrelvir), an oral antiviral, for...

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...

Neurizon Begins Dosing of NUZ-001 in HEALEY ALS Platform Trial

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...

FDA Grants KORU Medical Systems 510(k) Clearance for RYSTIGGO® Delivery via FreedomEDGE® Infusion System

KORU Medical Systems, Inc. a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, announced that the Company received...

Tonix Pharmaceuticals presented Phase 3 RESILIENT data on TONMYA™ (cyclobenzaprine HCl sublingual tablets) at the 2026 Non-Opioid Pain Therapeutics Summit

Tonix Pharmaceuticals Holding Corp. a fully integrated, commercial biotechnology company, presented data on TONMYA™, which was investigated as TNX-102 SL, at the 2026 Non-Opioid Pain Therapeutics Summit, on January 29, 2026, in Boston,...

Align Technology Supports Children and Teens With 30 Invisalign® Treatments via Smiles4Canada Program

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...

Coya Therapeutics Announces Results from an Investigator-Initiated Study Showing Treg Enhancement and Cognitive Stability in Frontotemporal Dementia Patients Treated with Low-Dose IL-2 and CTLA4-Ig

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...

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...

Illumina's Constellation Mapped Read technology uncovers hard-to-see genomic insights in the GeneDx pilot

Illumina, Inc. announced that GeneDx, a leader in genetic testing for rare diseases, is piloting Illumina's emerging constellation mapped read technology, evaluating its performance on regions of the genome that traditional short-read technologies...

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...

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...

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...

Biologic Therapy Improves Pregnancy Outcomes in High-Risk Antiphospholipid Syndrome Patients, Says HSS

A landmark clinical trial co-led by Hospital for Special Surgery (HSS) has found that blocking inflammation with the drug certolizumab significantly reduces the risk of serious adverse pregnancy outcomes in women with antiphospholipid syndrome...

Pint Pharma secures ANVISA approval for BESREMi® to treat Polycythemia Vera

Pint Pharma and PharmaEssentia announced that ANVISA (Brazilian Health Regulatory Agency) has approved BESREMi® (ropeginterferon alfa-2b) for the treatment of adult patients with Polycythemia Vera (PV). Polycythemia Vera (PV) is a rare, chronic,...

Supporting the lab of the future, MilliporeSigma partners with Opentrons Labworks, Inc

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, and Opentrons Labworks, Inc., a leader in lab automation and accessible robotics, announced a multi-year agreement to automate assay kits on a custom...

Neurophet gains FDA 510(k) clearance for Neurophet AQUA, advancing multiple sclerosis analysis with AI-driven precision

Neurophet, an artificial intelligence (AI) solution company for brain disease, announced on the "Neurophet AQUA", has obtained 510(k) clearance from U.S. Food and Drug Administration (FDA) for its newly integrated multiple sclerosis (MS) analysis...

Aadi Bioscience reports Q3 2024 financial results and updates on corporate progress

Aadi Bioscience, Inc. announced financial results for the third quarter ended September 30, 2024, and provided recent corporate progress. "The third quarter saw strong sales growth for FYARRO, backed by continued account momentum, increased demand...

Eisai strengthens its presence in Saudi Arabia by establishing a new pharmaceutical sales subsidiary to enhance its operations in the region

Eisai Saudi Arabia was established in April 2024 in order to build an in-house sales system. Japan-based Eisai Co. has announced that fully-fledged operations and business activities have begun at Eisai Pharmaceuticals Single Person Limited...

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