FDA Approves OTC Combination of Ibuprofen and Acetaminophen
The FDA has approved the first OTC fixed-dose combination therapy containing ibuprofen and acetaminophen for the temporary relief of minor pain.
All articles by Steve Duffy
Test for Fragile X Syndrome Screening, Diagnosis Gets FDA Clearance
A diagnostic test for fragile X syndrome (FXS) has been cleared by the Food and Drug Administration.
Investigational Therapies Miss Primary End Point in Autosomal Dominant Alzheimer Disease Trial
Topline data were announced from the phase 2/3 DIAN-TU study of solanezumab (Eli Lilly) and gantenerumab (Genentech) in patients at risk for or with dominantly inherited Alzheimer disease.
FDA Clears OTC Electromagnetic Pulse Therapy for Musculoskeletal Pain Relief
The over-the-counter (OTC), drug-free medical device, ActiPatch®, has obtained a new 510(k) clearance from the Food and Drug Administration (FDA) for the adjunctive treatment of musculoskeletal pain.
Supplemental NDA Submitted for Epidiolex for Tuberous Sclerosis Complex
Epidiolex is currently approved in the US to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
Deep Brain Stimulation System Gains Expanded Approval for Parkinson Disease Management
The FDA has approved an expanded indication for the Infinity™ Deep Brain Stimulation (DBS) system (Abbott) to include targeting the internal globus pallidus, which may lead to symptom improvement in patients with Parkinson disease.
FDA: Possible Cybersecurity Issues With Certain Patient Monitoring Devices
The FDA has issued a safety communication informing healthcare providers, facilities, and patients about cybersecurity vulnerabilities associated with certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
Haymarket Medical Education Receives Interprofessional Joint Accreditation for the Healthcare Team
Caroline O. Pardo, Ph.D., General Manager for Haymarket Medical Education, is pleased to announce that HME, based in Paramus, NJ, has been accredited as a provider of interprofessional continuing education by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nursing Credentialing Center.
FDA Grants Orphan Designation to Reldesemtiv for ALS
The FDA has granted Orphan Drug designation to reldesemtiv (Cytokinetics) for the treatment of amyotrophic lateral sclerosis.
Zotiraciclib Granted Orphan Drug Designation for Treatment of Glioma
The Food and Drug Administration (FDA) has granted Orphan Drug Designation to zotiraciclib (Adastra Pharmaceuticals) for the treatment of glioma.
