DelveInsight Blog
Map the latest in Pharmaceutical, Healthcare, Medical Devices and Biotech Space with DelveInsight’s panoramic market analysis while the Pharma Industry continues to rapidly evolve with several approvals,failures, acquisitions, and partnerships teeing up the domain.
Johnson & Johnson Medtech Acquired Laminar; BD Launched Advanced Vascular Access Ultrasound System; FDA Cleared Oral Device for Severe Sleep Apnea; FDA Clearanced the Zilia OcularTM FC Retinal Camera; First Patient Enrolled in Penumbra Study of Computer-assisted Vacuum Thrombectomy; US FDA Granted the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study
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 treating severe obstructive sleep apnea (OSA). With this FDA approval, Vivos Therapeutics became the first firm to approve and launch a viable therapy option for patients suffering with severe OSA other than CPAP or surgical neuro-stimulation implants. This latest approval marks the first time the FDA…
Assessing the Emerging Trends in the Evolving Implantable Drug Delivery Device Landscape
The Implantable Drug Delivery Device market has experienced a monumental surge driven by an amalgamation of technological innovation, burgeoning demand, and the strategic maneuvers of key industry players. According to DelveInsight's latest assessment, the global Implantable Drug Delivery Device Market is poised to achieve a 6.31% CAGR between 2023 and 2028. Technological advancements have emerged as the linchpin propelling the market's exponential growth trajectory. Innovations spanning microelectromechanical systems (MEMS), biodegradable materials, and smart sensors have revolutionized drug delivery, ushering in an era of precise, targeted, and sustained therapeutic interventions. This…
FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev; Roche and Carmot Therapeutics’s Definitive Merger Agreement; AbbVie to Acquire ImmunoGen; FDA Grants Orphan Drug Designation to LP-284; Merck Announces Commercialization Agreement With Abbisko; Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial
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 supplementary Biologics License Application (sBLA). This application focuses on obtaining approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in conjunction with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate. The intended use is for treating adult patients dealing with locally advanced or metastatic urothelial carcinoma (la/mUC). The FDA is expediting…
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