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. […]
FDA approves Flowonix’s Prometra II programmable pump
Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and its associated software for intrathecal infusion. The pump has expanded reservoir size options that include 20 ml and 40ml pumps, along with the claim of 10-year battery life at average flow rates. Flowonix said in a news release yesterday that […]
Clearside Biomedical inks $76m licensing deal with Bausch for Xipere
Clearside Biomedical (NSDQ:CLSD) said yesterday that it entered into a license agreement with Bausch Health Ireland (NYSE:BHC) worth up to $76 million for the Xipere device for the treatment of macular edema associated with uveitis. The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device. Bausch agreed to […]
Aptar Pharma’s two-dose nasal spray device to deliver epinephrine
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 […]
Clearside Biomedical confirms timeline for Xipere
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 […]
FDA approves Philips’ low-dose Stellarex balloons
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 […]
Intarcia Therapeutics takes another run at FDA approval
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 […]
Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA
Frequency Therapeutics (NSDQ:FREQ) said today that it launched a Phase 2a study and won fast-track designation at the FDA for its regenerative hearing loss drug. The fast-track program aims to speed up the approval of therapies for unmet needs in serious conditions. Woburn, Mass.-based Frequency’s FX-322 candidate is designed to stimulate the regrowth of sensory hair cells […]
Dexcom wins FDA clearance for G6 Pro CGM
Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro continuous glucose Monitor for diabetic patients ages ages two years and up. The San Diego-based company said the G6 Pro is designed to measure glucose data in real time over 10 days in either “blinded” or “unblinded mode,” depending on […]
Intersect ENT’s Ascend study misses endpoint
Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus […]
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