The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S. The approval covers the prevention of COVID-19 in individuals 16 years of age and older. In addition, the vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years […]
FDA
FDA approves, expands label for Eli Lilly’s rapid-acting insulin for infusion
Eli Lilly (NYSE:LLY) announced today that it received FDA approval and expanded labeling for its Lyumjev rapid-acting insulin. Indianapolis-based Eli Lilly’s Lyumjev (insulin lispro-aabc injection) 100 units/mL holds indication to improve glycemic control in adults with type 1 and type 2 diabetes, including administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. Get the […]
Baxter has a serious recall involving infusion pump software
The FDA issued a Class I recall — the most serious kind of recall — for Baxter’s Dose IQ safety software program. Baxter designed its Dose IQ safety software as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into […]
ProPublica report raises questions about FDA’s handling of Medtronic’s HVAD
A recent ProPublica report highlighted potential failings by the FDA in the handling of Medtronic’s HVAD system. In June, Medtronic stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system amid a slew of clinical comparisons indicating a higher frequency of neurological adverse events, including stroke and mortality, with the HVAD system. The company had previously recalled […]
FDA clears Boston Scientific’s Exalt Model B single-use bronchoscope
Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its Exalt Model B single-use bronchoscope. Marlborough, Mass.-based Boston Scientific designed the Exalt Model B for use in bedside procedures within the intensive care unit and operating room, according to a news release. Uses for the device include a wide range of bronchoscopy […]
HHS OIG will review FDA’s approval of Biogen’s aducanumab
The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523). Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. […]
FDA approves Kestra Medical Technologies’s wearable cardioverter defibrillator
Kestra Medical Technologies announced today that it received FDA approval for its Assure wearable cardioverter defibrillator (WCD) system. Kirkland, Wash.-based Kestra designed its Assure WCD system as a modern, comfortable wearable device with integrated sensors, a cardiac rhythm monitor and a miniaturized automated external defibrillator, according to a news release. The system, designed to protect […]
Abbott wins FDA clearance for AI-based heart vessel imaging tech
Abbott (NYSE:ABT) announced today that it received FDA clearance for its latest optical coherence tomography (OCT) imaging platform. Powered by the company’s new Ultreon software, the latest imaging platform combines OCT with artificial intelligence (AI) to provide physicians with an enhanced, comprehensive view of coronary blood flow and blockages to aid in physician decision-making, according […]
Vaxart stock soars after FDA approves IND application for oral COVID-19 vaccine tablet
Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. Get the full story at our sister site, Drug Delivery Business […]
BD begins remediation in Alaris infusion system software recall
BD (NYSE:BDX) announced today that it will begin remediation for a 2020 Class I-level recall of its Alaris infusion system. Franklin Lakes, N.J.–based BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes, with pumps only going to health providers […]
FDA approves insulin glargine biosimilar injection from Viatris, Biocon Biologics
Viatris (NSDQ:VTRS) and Biocon Biologics announced FDA clearance for their Semglee insulin glargine-yfgn injection as a biosimilar. Semglee holds an indication for controlling high blood sugar in adults with type 2 diabetes and pediatric patients with type 1 diabetes. The FDA approved Semglee as the first interchangeable biosimilar product under the 351(k) regulatory pathway. The product is sold […]