Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Diurnal, Elsalys, Exelixis, Fibrogen, GSK, Illuminare, Kintor, Mitochem, Vir.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reverses HHS premarket notification exemptions; ITC will check findings for Zimmer/Heraeus dispute.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perimeter Medical Imaging AI.
The latest global regulatory news, changes and updates affecting biopharma, including: WHO: Antibiotic pipeline nearly static, Canada creates new drug safety net, CDSCO provides guidance on COVID-19 vaccines.
The current pause on administering Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine likely will continue in the U.S. after the CDC’s Advisory Committee on Immunization Practices (ACIP) declined to make a recommendation on a path forward April 14.
The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Astrazeneca, Cormedix, Gilead, Moleac, Moleculin, Praxis, Tetra.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS may reverse non-coverage for catheter pulmonary embolectomy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Oncosec Medical.