Abbott FDA OK for OTC sensor

Abbott has received clearance from the Food and Drug Administration in the USA for an over-the-counter (OTC) glucose monitor. The device, called Lingo, first debuted in the U.K. last year as a sensor for people who do not have diabetes to track glucose spikes. Abbott now hopes to bring it to the U.S. and, with […]

Monthly News Roundup - June 2024

drugs.com - 30/Jun 00:06

FDA Grants Expanded Approval to Skyrizi for Ulcerative Colitis On June 18th, the U.S. Food and Drug Administration (FDA) approved AbbVie’s...

Perth biotech Botanix to raise $70m following FDA nod for sweat-stopper gel

thewest.com.au - 21/Jun 03:24

Biotech Botanix says it has received firm commitments to raise $70 million from institutional investors just a day after it received US Food and Drug...

AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)

drugs.com - 25/Jun 21:06

NORTH CHICAGO, Ill., June 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food...

FDA expands orphan drug designation for Roswell Park's brain cancer immunotherapy

news.medical.net - 25/Jun 14:52

The U.S. Food and Drug Administration (FDA) has expanded orphan drug designation for SurVaxM, a brain cancer immunotherapy born in the labs of Roswell...

New glucose monitoring tech enhances diabetes care in Việt Nam

vietnamnews.vn - 28/Jun 10:39

The Vietnam Association of Diabetes and Endocrinology introduced the first continuous glucose monitoring protocol guideline to healthcare...

Newsdeck: US FDA approves Lilly’s Alzheimer’s drug

daily maverick - 02/Jul 19:01

July 2 - The U.S. Food and Drug Administration on Tuesday gave a green light to Eli Lilly's LLY.N donanemab for patients with early Alzheimer's,...

FDA Expands Pediatric Indication for Rinvoq

drugs.com - 21/Jun 23:00

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has expanded indications for Rinvoq (upadacitinib) to now include pediatric patients...

Unilab lauds FDA’s proactive measures vs fake drugs

philstar.com - 24/Jun 04:00

Pharmaceutical and healthcare company Unilab Inc. lauded the Food and Drug Administration (FDA) for taking proactive measures to protect the public...

Sarepta Therapeutics Announces Expanded US FDA Approval of Elevidys to Duchenne Muscular Dystrophy Patients Ages 4 and Above

drugs.com - 20/Jun 23:06

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 20, 2024-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare...

New research indicates the need for diabetes continuous glucose monitoring to address health disparities

pharmabiz.com - 24/Jun 00:00

Results from a new study show the impact and importance of continuous glucose monitoring (CGM) that young individuals with diabetes face today. The...

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