• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA

Locate Bio lands FDA breakthrough nod for bone infection device

January 7, 2021 By Nancy Crotti

Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Orthopedics, Pharmaceuticals, Regenerative Medicine Tagged With: FDA, Locate Bio

FDA produces list of ‘essential’ devices, drugs for health, military emergencies

November 2, 2020 By Nancy Crotti

FDA-logo-new

The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that the Trump administration ordered the agency to buy domestically to fight the novel coronavirus and future health and military crises. Devices on the list include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, devices […]

Filed Under: Cardiovascular, Drug-Device Combinations, Hospital Care, Patient Monitoring, Pharmaceuticals, Respiratory Tagged With: Donald Trump, FDA

Report: Will Dr. Hahn crack under political pressure?

August 10, 2020 By Nancy Crotti

Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration. Hahn has been squeezed between expressing his professional […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Centers for Disease Control & Prevention, coronavirus, COVID-19, Donald Trump, FDA, U.S. Department of Health & Human Services

Tandem Diabetes Care wins expanded FDA indication for insulin pump

June 17, 2020 By Sean Whooley

Tandem Diabetes Care - updated logo

Tandem Diabetes Care (NSDQ:TNDM) announced today that it won an expanded pediatric indication from the FDA for its t:slim X2 insulin pump. The t:slim X2 with Control-IQ technology won FDA clearance for controlling Type 1 diabetes in December, which was followed by a commercial launch in the U.S. the next month. Tandem touts t:slim X2 with […]

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

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance, Vascular Tagged With: B. Braun Medical, Biosensors International, Biotronik, Boston Scientific, cook medical, FDA, Lutonix, LVD Biotech, Medtronic, Spectranetics, UK Medicines and Healthcare products Regulatory Agency

Clinical trials ramping up for potential coronavirus-fighting drugs

April 13, 2020 By Sean Whooley

Bausch Health (NYSE:BHC) announced today that it initiated a clinical trial program in Canada to investigate the use of Virazole for treating COVID-19. With today’s announcement, Bausch joins Eli Lilly (NYSE:LLY) and Care Access Research, which both announced clinical testing of coronavirus therapies last week. Bausch’s Virazole is currently approved in the U.S. and Canada, among other […]

Filed Under: Business/Financial News, Clinical Trials, Diagnostics, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Bausch Health, Care Access Research, coronavirus, COVID-19, elililly, FDA

FDA approves Cipla’s generic albuterol inhaler

April 9, 2020 By Sean Whooley

FDA-logo-new

The FDA approved the first generic version of the Proventil HFA (albuterol sulfate) metered-dose inhaler for treating bronchospasm. The FDA indicated the generic inhaler from Cipla for the treatment or prevention of bronchospasm in patients four years of age or older with reversible obstructive airway disease. It also aids in the prevention of exercise-induced bronchospasm […]

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

Companion Medical wins FDA nod for InPen diabetes management system

February 28, 2020 By Sean Whooley

Companion Medical

Companion Medical announced that it won FDA clearance for its InPen bolus calculator for fixed dosing and meal estimation in diabetes management. The new bolus calculator is designed to account for the user’s current glucose level and active insulin to remove the guesswork from insulin dosing. Companion Medical touts the system as the first of […]

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance Tagged With: Companion Medical, FDA

7 medtech advances to improve diabetes treatment

January 10, 2020 By Sean Whooley

Medtech and pharmaceutical companies have made several important strides over the past year when it comes to improving diabetes treatment. Multiple treatments and technologies have cleared regulatory hurdles and are now hitting the market and making the process of living with diabetes that much more manageable. Several different styles of therapy and devices have come […]

Pages: Page 1 Page 2

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Technology Tagged With: dariohealth, FDA, Medtronic, Novo Nordisk, One Drop, optiscanbiomedical, popsdiabetescare, Senseonics, Tandem Diabetes Care, Valeritas Inc.

FDA wants feedback on combination products guidance

December 27, 2019 By Nancy Crotti

FDA-logo-new

The FDA is seeking comment from sponsors of combination products on how they want the agency to respond to their scientific and regulatory questions. Their responses will help shape a new draft guidance, according to the agency. The FDA defines a combination product as one composed of any combination of a drug, device and/or a […]

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

  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Interim pages omitted …
  • Go to page 7
  • Go to Next Page »

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by DrugDeliveryNow

Footer

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
Medical Tubing + Extrusion

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery News
Advertise with us
About
Contact us
Privacy
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS