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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...

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...

FDA Clears Roche's cobas® BV/CV Assay, Enabling Fast and Highly Accurate Diagnosis of Vaginitis

Roche announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and...

China Approves Haisco's Class 1 Innovative Drug, Ciprocopan Succinate Tablets, Providing a New Treatment Option for Patients with PNH

Haisco Pharmaceutical Group claimed today their independently developed Class 1 innovative drug, Ciprocopan Succinate Tablets (development code: HSK39297), has received marketing approval from the National Medical Products Administration of China...

Children's Hospital of Philadelphia Initiative Substantially Increases Naloxone Co-Prescribing When Prescribing Outpatient Opioids

A multidisciplinary team at Children's Hospital of Philadelphia (CHOP) substantially increased naloxone co-prescribing for patients prescribed outpatient opioid prescriptions through an enterprise-wide quality improvement initiative designed to...

BioMarin's Supplemental New Drug Application for Full Approval of VOXZOGO® (vosoritide) for Children With Achondroplasia Accepted by the U.S. Food and Drug Administration

BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for full approval in children with achondroplasia. . "This...

Nnamdi Njoku Named President of Omnicell

Omnicell, Inc. a leading healthcare technology provider focused on empowering autonomous medication management, announced that Nnamdi Njoku has been appointed President of the Company, effective July 1, 2026. Mr. Njoku will retain his role of...

Eligible Medicare Beneficiaries Living with Obesity Can Now Access Wegovy® Through the Medicare GLP-1 Bridge

Starting today FDA-approved Wegovy® (semaglutide) is available through the Medicare GLP-1 Bridge, a new access pathway for millions of older adults living with obesity. Obesity is a serious, common chronic disease among older Americans and Wegovy®...

Johnson & Johnson Strengthens European Cardiac Care with the Introduction of the Dual Energy THERMOCOOL SMARTTOUCH SF Ablation Platform

Johnson & Johnson announced the commercial launch of the Dual Energy THERMOCOOL SMARTTOUCH SF (DE STSF) Platform in Europe, expanding physician access to a dual-energy catheter ablation solution designed for personalized care across workflows,...

Zeta Surgical® has announced the successful treatment of the first patient using its Zeta TMS Navigation System at HOPE Therapeutics.

ZETA SURGICAL and HOPE Therapeutics, an NRx Pharmaceuticals company announced the first patient treatment with the FDA-cleared Zeta TMS Navigation System at a HOPE Therapeutics clinic in Sarasota. HOPE has installed Zeta TMS Navigation Systems at...

Upsher-Smith Expands KYMBEE™ (Deflazacort) Family of Products with Launch of Oral Suspension for the Treatment of Duchenne Muscular Dystrophy

Upsher-Smith Laboratories, LLC (Upsher-Smith), a subsidiary of Bora Pharmaceuticals Co., Ltd. (6472.TW and BORAY.OTCQX) today announced the launch of KYMBEE™ (deflazacort) Oral Suspension, 22.75 mg/mL indicated for the treatment of Duchenne...

Bayer’s AMBELVIST® (gadoquatrane) Gains FDA Approval for Contrast-Enhanced MRI in Detection of Lesions with Abnormal Vascularity Across CNS and Non-CNS Body Regions

Bayer announced that the U.S. Food and Drug Administration (FDA) approved AMBELVIST® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to...

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...

Lundbeck Receives Marketing Authorization in South Korea for Vyepti® (eptinezumab) for the Preventive Treatment of Migraine

H. Lundbeck A/S (Lundbeck) announced that the Ministry of Food and Drug Safety (MFDS) of South Korea has granted marketing authorization for eptinezumab for use in adults with migraine. Migraine is a progressive and debilitating neurological...

Novo Nordisk’s Ozempic pill—the only FDA-approved oral peptide GLP-1 for adults with Type 2 Diabetes—will soon be available in the U.S

Novo Nordisk announced that starting Monday, May 4, Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg will be available for adults with type 2 diabetes in the US. Ozempic® is the only FDA-approved oral peptide GLP-1 medication for adults with...

TIME names Sprout Pharmaceuticals, the maker of Addyi (flibanserin), among the 10 most influential health and life science companies of 2026

TIME has named Sprout Pharmaceuticals among just 10 organizations globally shaping the future of health and life sciences. This recognition follows a defining period of momentum for Sprout and its flagship treatment, Addyi. In December 2025, the...

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