These Food and Drug Administration (FDA) approvals were recently announced.
Hayes News
Hayes News Service keeps our clients up to date with late-breaking news from clinical trials, coverage decisions, and new product approvals. We focus on emerging technologies with potentially high clinical and financial impact as soon as they are announced publicly.
Our analysts scan more than 75 peer-reviewed journals and news briefings from government agencies, medical associations, and research institutes. Results of selected studies or articles are summarized and posted with a brief commentary on whether the findings are likely to have a substantial impact.
FDA Safety Alert: Medtronic HVAD Pump Implant Kits
The Food and Drug Administration (FDA) has announced a recall of specific lots of the Medtronic HVAD pump implant kits due to a possible delay or failure to start.
FDA Issues EUA for Third COVID-19 Vaccine
The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 18 years of age and older.
FDA Approves Targeted Treatment for Rare DMD Mutation
The Food and Drug Administration (FDA) has granted approval for Amondys 45 (casimersen; Sarepta Therapeutics Inc.) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
FDA Safety Alert: Medtronic Valiant Navion
The Food and Drug Administration (FDA) has announced a voluntary recall of unused Medtronic Valiant Navion thoracic stent graft systems.
FDA Safety Alert: EMBLEM S-ICD
The Food and Drug Administration (FDA) has announced a recall of specific lots of the Boston Scientific EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) due to a manufacturing error.
FDA Grants Humanitarian Device Exemption for 3D Orthopedic Implant
The Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) for the Patient Specific Talus Spacer 3D-printed talus implant (Additive Orthopaedics LLC).
Symplr Closes Its Acquisition of Phynd
SANTA MONICA, CA and HOUSTON, TX – February 16, 2021 —(PRNEWSWIRE)— symplr, a leading global healthcare governance, risk management, and compliance (“GRC”) software-as-a-service (“SaaS”) company, backed by Clearlake Capital Group, L.P. (together with its affiliates,...
FDA News Briefs
These Food and Drug Administration (FDA) developments recently came in.
FDA Safety Alert: Xeljanz
The Food and Drug Administration (FDA) reports that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Xeljanz/Xeljanz XR (tofacitinib; Pfizer) compared with tumor necrosis factor (TNF) inhibitors.