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Food & Drug Administration (FDA)

FDA awards product development grants for rare diseases

October 18, 2016 By Sarah Faulkner

FDA

The FDA said yesterday that it awarded 21 clinical trial research grants totaling more than $23 million over the next 4 years to stimulate product development for patients with rare diseases. The Orphan Products Clinical Trials Grants Program has awarded more than $370 million to fund more than 590 clinical studies since its creation in […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Funding Roundup, Implants, Neurological, Oncology, Pediatrics

FDA approves Genentech’s Lucentis pre-filled ranibizumab syringe

October 14, 2016 By Sarah Faulkner

Genentech

Genentech, a member of the Roche group (PINK:RHHBY), said today that it won FDA clearance for its Lucentis (ranibizumab injection) pre-filled syringes. The anti-VEGF medicine is FDA-approved to treat wet age-related macular degeneration and macular edema after retinal vein occlusion. The pre-filled syringe enables physicians to eliminate steps in preparation and administration process, the company […]

Filed Under: Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: Genentech, Roche

Parents question Mylan’s EpiPen school campaign

September 23, 2016 By Sarah Faulkner

Mylan

Three years ago, Mylan (NSDQ:MYL) began holding summits for food allergy bloggers to learn about its campaign to get its EpiPen epinephrine injector into schools. Many of the bloggers, mothers of children with serious allergies, were eager to help. Some, including Ruth LovettSmith, wrote thousands of posts, providing testimony that some legislators say convinced them […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Mylan

FDA approves clinical trial for QT Vascular’s Chocolate Touch DCB

September 20, 2016 By Sarah Faulkner

QT Vascular

QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon. The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. The Singapore-based company is slated to […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: AngioScore Inc., Peripheral Artery Disease, QT Vascular

FDA approves Bayer’s Kyleena IUD

September 20, 2016 By Sarah Faulkner

Bayer

Bayer (ETR:BAYN) said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years. The German company said the long-acting reversible contraceptive (LARC) is due to hit the market next month. LARCs are an increasingly popular form of birth control, including intrauterine devices like Kyleena. Bayer’s […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Women's Health Tagged With: Bayer HealthCare, Teva Pharmaceuticals

Ablative Solutions wins FDA nod for Phase II chemical denervation trial

September 13, 2016 By Sarah Faulkner

Ablative Solutions

Ablative Solutions said today that the FDA approved a Phase II trial of its chemical denervation system for hypertension under its investigational new drug application. The trial, called Target-BP I, will evaluate the efficacy of Ablative’s Peregrine infusion ablation system, which uses ethanol to interrupt signals from sympathetic nerves in the renal artery to control […]

Filed Under: Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: Ablative Solutions, Hypertension, Medtronic, St. Jude

Teva plans competitor for Mylan’s EpiPen

September 12, 2016 By Sarah Faulkner

Teva Pharmaceuticals, Mylan

Teva Pharmaceutical (NYSE:TEVA) said last week that it hopes to win U.S. approval for its version of Mylan‘s (NSDQ:MYL) EpiPen by late 2017 or early 2018. Mylan’s EpiPen holds an estimated 94% market share in the U.S.; an alternate device from Teva could threaten the product’s dominance. Teva’s application for its epinephrine injector has been […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Wall Street Beat Tagged With: Mylan, Teva Pharmaceuticals

FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for diabetes

August 24, 2016 By drugdelivery

By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL) said last week. Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to […]

Filed Under: Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: Sanofi-Aventis, Zealand Pharma

FDA draft guidance on 510(k)s omits combination devices

August 10, 2016 By Fink Densford

Combination medical devices which bring together device components and drugs or biological products into a single unit are missing from new draft guidance from the FDA. The guidance, released last week, covered recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market, replacing guidance that was 19 years […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance

Intersect ENT files with FDA for drug-delivering sinus implant

August 1, 2016 By Fink Densford

Intersect ENT (NSDQ:XENT) said today it submitted a supplemental premarket approval submission to the FDA seeking approval for a new Nova steroid releasing implant for treating patients with chronic sinus disease. The new Nova device is designed with a lower profile to allow for placement in smaller sinus openings, and will expand the usable patient population for […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Otolaryngology Ear, Nose & Throat, Regulatory/Compliance Tagged With: Intersect ENT Inc.

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