Search results for "FDA update"

Results 41 - 50 of about 58 for "FDA update".

Recall, warning, and a new generic drug

Certain batches of NovoPen Echo insulin cartridge holders are being recalled by the manufacturer because they may crack or break if exposed to certain chemicals, such as cleaning agents, the FDA ... The FDA also announced on May 19 that it approved the
July 2017

Canagliflozin will receive new boxed warning about amputation risks

Canagliflozin (Invokana, Invokamet) increases patients' risk of leg and foot amputations, according to new data from two clinical trials, the FDA recently announced. ... Canagliflozin (Invokana, Invokamet) increases the risk of leg and foot amputations
June 2017

First continuous glucose monitoring system with fully implantable glucose sensor approved

The first FDA-approved continuous glucose monitoring system with a fully implantable glucose sensor has been cleared for use in adults with diabetes, the agency announced on June 21.
July 2018

FDA update

The FDA has approved the first treatment for severe hypoglycemia that can be administered without an injection, the agency announced on July 24.
August 2019

FDA update

Patients should not use unapproved or unauthorized devices for diabetes management, either alone or with authorized devices, the FDA recently warned. ... In one report, a patient used an unauthorized device that received the electronic signal from an
June 2019

Glucose monitoring app, weight-loss device, medications approved

The clinical study did not meet its original end point, but the FDA concluded that the benefits outweighed risks of the device, according to a press release. ... Other adverse events included pain, heartburn, problems swallowing, belching, mild nausea,
February 2015

FDA update

The FDA has approved an oral formulation of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, to help improve blood glucose control in adults with type 2 diabetes. ... The FDA recently approved semaglutide (Rybelsus) oral tablets, the
October 2019

Alert on canagliflozin and amputations

An ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with canagliflozin (Invokana, Invokamet), according to an FDA safety alert.
June 2016

New indication approved for empagliflozin

Empagliflozin (Jardiance) is approved for a new indication—to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease, the FDA announced on Dec. ... The most common side effects are urinary tract infections and
December 2016

New long-acting insulin drugs approved

Insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg 70/30) were approved by the FDA on Sept. ... Both drugs are contraindicated for patients with diabetic ketoacidosis, according to an FDA.
October 2015

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