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Food & Drug Administration (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

OncoSec, Inovio testing COVID-19 vaccines

April 8, 2020 By Sean Whooley

OncoSec Medical (NSDQ:ONCS) and Inovio Pharmaceuticals (NSDQ:INO) announced that they are testing potential COVID-19 vaccines after the latter received investigational new drug clearance from the FDA. Inovio received an IND nod, while OncoSec’s is pending, but both companies are pursuing a first-in-human Phase 1 clinical trial for their vaccines, according to separate news releases. OncoSec is using […]

Filed Under: Business/Financial News, Clinical Trials, Discovery, Featured, Food & Drug Administration (FDA), Immunotherapy, Pharmaceuticals, Preclinical Trials, Regulatory/Compliance, Research & Development, Respiratory Tagged With: coronavirus, COVID-19, Inovio Pharmaceuticals, OncoSec Medical

FDA approves BioStage’s esophageal device investigational new drug application

March 25, 2020 By Danielle Kirsh

Biostage prices $8m offering for bioengineered organ implants

Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]

Filed Under: Food & Drug Administration (FDA), Implants, Regulatory/Compliance Tagged With: Biostage

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 […]

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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

Smiths Medical recalls Medfusion 4000 due to issue with software update

December 19, 2019 By Sean Whooley

Smiths Medical

Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the recall as Class I, it’s most serious designation. The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s […]

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

FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller

December 13, 2019 By Nancy Crotti

The FDA today cleared the Tandem Diabetes Care (NSDQ:TNDM)  t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The agency also granted De Novo clearance to the Control-IQ device, which is compatible with a variety of continuous glucose monitors and insulin pumps. The t:slim system, which also includes the recently […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: artificialpancreas, DexCom Inc., FDA, Tandem Diabetes Care

Senate confirms Dr. Stephen Hahn to lead FDA

December 12, 2019 By Nancy Crotti

The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer at Houston’s […]

Filed Under: Food & Drug Administration (FDA) Tagged With: AdvaMed, Dr. Stephen Hahn, FDA

Beta Bionics’ bionic pancreas wins breakthrough status from FDA

December 11, 2019 By Nancy Crotti

Beta Bionics - updated logo

The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device  — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Beta Bionics, FDA, Zealand Pharma

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