FDA

FDA Cleared Oral Device for Severe Sleep Apnea From Vivos Therapeutics On November 29, 2023, Vivos Therapeutics announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Vivos’s removable CARE (Complete Airway Repositioning and Expansion) oral appliances developed for treat...

FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementar...

Ethicon Announced European Approval and Introduction of ETHIZIA™ Hemostatic Sealing Patch Used to Stop Disruptive Bleeding On November 15, 2023, Ethicon, a Johnson & Johnson MedTech company, received approval for ETHIZIA™, an adjunctive hemostat solution that has been clinically proven to achieve sustained h...

GE HealthCare and Masimo Collaborated on Patient Monitoring Tech On November 8, 2023, GE HealthCare and Masimo announced a joint agreement to integrate patient monitoring technologies.  The goal of the partnership is to incorporate Masimo Signal Extraction Technology (SET) pulse oximetry into GE HealthCa...

Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea The Global Antibiotic Research & Development Partnership (GARDP), in partnership with Innoviva, Inc. (Nasdaq: INVA), had announced a significant milestone. They revealed that zolif...

Neurovalens Received US FDA Clearance for Non-Invasive Insomnia-Treating Device  On October 30, 2023, Belfast, Northern Ireland-based Neurovalens announced the US Food and Drug Administration clearance for its Modius Sleep device meant for treating chronic insomnia.  Modius has been designed to deli...

FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...

South Rampart Pharma Receives U.S. FDA Fast Track Designation for SRP-001 for Acute Pain On October 12, 2023, South Rampart Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track status to its drug candidate, SRP-001, intended for the management of acute pain. SRP-001 is a...

B. Braun Launched Introcan Safety® 2 IV Catheter with Multi-Access Blood Control Designed to Protect Clinicians Every Time the Hub is Accessed On October 11, 2023, B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy, announced the launch of its new Introcan Safety® 2 IV Catheter with Multi-Acces...

Sanofi and Teva Announce Exclusive Collaboration to Deliver Inflammatory Bowel Disease Treatment Sanofi and Teva Pharmaceuticals, a subsidiary of Teva Pharmaceutical Industries Ltd. in the United States, have announced a collaboration to co-develop and co-commercialize asset TEV'574, which is currently in Phase ...