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Food & Drug Administration (FDA)

FDA lifts hold on Vertex’s insulin-producing cell therapy for diabetes

July 5, 2022 By Sean Whooley

Vertex Pharmaceuticals

Vertex Pharmaceuticals (Nasdaq:VRTX) announced today that the FDA lifted the clinical hold placed on the Phase 1/2 trial of VX-880. Boston-based Vertex designed VX-880 as a stem cell-derived fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. It could potentially restore the body’s ability […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Vertex Pharmaceuticals

Virpax to pursue over-the-counter pathway for topical spray treatment for osteoarthritis pain

June 27, 2022 By Sean Whooley

Virpax

Virpax Pharmaceuticals (Nasdaq:VRPX) announced today that it will pursue a direct to over-the-counter (OTC) regular pathway for Epoladerm. Berwyn, Pennsylvania–based Virpax designed the Epoladerm investigational pre-filled topical spray analgesic product for the non-addictive management of chronic pain associated with osteoarthritis (OA) of the knee. According to a news release, the company expects the direct to […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pain Management, Pharmaceuticals, Regulatory/Compliance Tagged With: Virpax Pharmaceuticals

FDA grants breakthrough nod for Carthera’s SonoCloud-9

June 22, 2022 By Sean Whooley

Carthera SonoCloud

Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound to […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance Tagged With: Carthera, FDA

First patient enrolled in MedAlliance’s drug-eluting balloon trial

June 8, 2022 By Sean Whooley

MedAlliance SELUTION SLR

MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon. Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA), Vascular Tagged With: MedAlliance

Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery

June 7, 2022 By Sean Whooley

Dexcom G7

With the G7 nearing FDA clearance, Dexcom leadership foresees major innovations for integrated automated insulin delivery down the line. Kevin Sayer began thinking about automated insulin delivery all the way back in 1994 when he was working at MiniMed. Nearly 30 years later, as CEO of Dexcom (Nasdaq:DXCM), that space continues to pique his interest. […]

Filed Under: Auto-injectors, Business/Financial News, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Dexcom, Insulet, Tandem Diabetes Care

Real-world data backs Medtronic’s next-gen MiniMed 780G insulin pump

June 6, 2022 By Sean Whooley

Medtronic MiniMed 780G

Medtronic (NYSE:MDT) announced positive real-world data supporting its next-generation MiniMed 780G insulin pump system. Results from real-world analyses in Europe and Chile, along with clinical data, were presented by Medtronic at the American Diabetes Association (ADA) 82nd Scientific Sessions in New Orleans. According to a news release, the MiniMed 780G advanced hybrid closed loop system, […]

Filed Under: Auto-injectors, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring Tagged With: American Diabetes Association, Medtronic

Abbott to develop biowearable for continuous monitoring of glucose, ketone levels

June 3, 2022 By Sean Whooley

Abbott logo updated

Abbott (NYSE:ABT) announced today that it is developing a new biowearable for continuously monitoring both glucose and ketone levels. The all-in-one sensor has already garnered FDA breakthrough device designation and will be used in pivotal trials in 2023, with regulatory submissions to follow thereafter. Abbott Park, Illinois-based Abbott said in a news release that the […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Pediatrics, Regulatory/Compliance Tagged With: abbott

FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter

May 31, 2022 By Sean Whooley

Medtronic In.Pact 018 drug-coated balloon catheter

Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]

Filed Under: Cardiovascular, Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Vascular Tagged With: FDA, Medtronic

FDA clears Abbott’s next-gen FreeStyle Libre 3 14-day CGM

May 31, 2022 By Sean Whooley

Abbott FreeStyle Libre 3 sensor pennies CGM diabetes

Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation FreeStyle Libre 3 continuous glucose monitor. FDA clearance for the latest iteration of the company’s FreeStyle Libre platform — designed as the smallest and thinnest CGM sensor in the world — covers use by people 4 years of age and older living with […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: abbott, FDA

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

May 26, 2022 By Sean Whooley

MedAlliance SELUTION SLR

MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Selution SLR features unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Vascular Tagged With: MedAlliance

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