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 […]

CamAPS FX FDA approval

desang.net - 18/Jun 07:37

CamDiab has received authorisation from the Food and Drug Administration (FDA) in the US for its advanced adaptive hybrid closed-loop app, CamAPS FX,...

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...

KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-demand Treatment for HAE

haei.org - 18/Jun 10:03

KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-demand Treatment for Hereditary Angioedema KalVista Pharmaceuticals,...

Dexcom ONE+ sensor launched

desang.net - 18/Jun 09:26

Dexcom has announced that it has launched the Dexcom ONE+ continuous glucose monitor (CGM) in the UK. Dexcom ONE+ uses Dexcom’s established sensor...

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...

FDA approves selpercatinib for RET fusion-positive thyroid cancer

oncologynews.com.au - 18/Jun 16:50

On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and...

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...

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...

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