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Tusker Medical’s pediatric ear tubes land breakthrough device designation

November 26, 2019 By Nancy Crotti

The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pediatrics, Research & Development Tagged With: FDA, Tusker Medical

Medtronic warns patients of MiniMed insulin pump safety issue

November 22, 2019 By Nancy Crotti

Medtronic Minimed 630g

Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin. In a letter to patients, the company said that the pump’s insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping […]

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA), Recalls Tagged With: FDA, Medtronic, minimed

FDA approves expanded indication for Liletta 6-year IUD

October 28, 2019 By Sean Whooley

Allergan, Medicines360

Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Women's Health Tagged With: Allergan, FDA, Medicines360

Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin

October 28, 2019 By Sean Whooley

Insulet

Insulet (NSDQ:PODD) said last week that it won FDA clearance for the use of Novo Nordisk‘s (NYSE:NVO) Fiasp insulin with the Omnipod insulin management platform. Acton, Mass.-based Insulet said it completed extensive testing to ensure that Fiasp is safe and usable with the Omnipod and Omnipod Dash systems. It’s the first insulin pump in the U.S. […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: FDA, Insulet, Novo Nordisk

Aptar Pharma’s two-dose nasal spray device to deliver epinephrine

October 21, 2019 By Nancy Crotti

Aptar Pharma has entered an agreement for Bryn Pharma to use Aptar’s Bidose (BDS) nasal device to deliver Bryn’s epinephrine nasal spray (BRYN-NDS1C). Crystal Lake, Ill.-based Aptar’s Bidose tech enables two-shot nasal drug delivery and will replace the need to carry two epinephrine auto-injectors, according to the companies. Last March, Aptar won FDA approval to […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: aptarpharma, Bryn Pharma, FDA

Clearside Biomedical confirms timeline for Xipere

October 21, 2019 By Sean Whooley

Clearside Biomedical logo - updated

Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported […]

Filed Under: Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Clearside Biomedical, FDA

FDA approves Philips’ low-dose Stellarex balloons

October 15, 2019 By Sean Whooley

philips-logo

Royal Philips (NYSE:PHG) said today that two of the company’s new Stellarex drug-coated balloons received FDA approval for the treatment of upper leg artery blockages. The approval was for both de novo and restenotic lesions in upper leg arteries. The Amsterdam-based company said the new low-dose (200 mm and 150 mm) balloons will be added to […]

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

Intarcia Therapeutics takes another run at FDA approval

October 15, 2019 By Sean Whooley

Intarcia Therapeutics

Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants Tagged With: FDA, Intarcia Therapeutics

FDA clears Insulet’s OmniPod Dash as insulin pump alternative

September 23, 2019 By Sean Whooley

Insulet

Insulet (NSDQ:PODD) said today that it won FDA clearance to market its Omnipod Dash alternate controller-enabled (ACE) infusion pump as an integrated insulin pump. The Acton, Mass.-based company received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device earlier this year. The latest indication states that the pump can reliably and […]

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

Orchestra BioMed wins breakthrough nod for Virtue SEB

September 17, 2019 By Sean Whooley

orchestra-biomed-logo

Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. The New Hope, Pa.-based […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: FDA, orchestrabiomed, Terumo Corp.

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