Remove tag breakthrough-device-designation
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PharmaShots Weekly Snapshots (April 24 - 28, 2023)

PharmaShots

Difficile Infection Date: Apr 27, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, C.

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PharmaShots Weekly Snapshots (January 23 - 27, 2023)

PharmaShots

Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)

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PharmaShots Weekly Snapshots (April 10 - 14, 2023)

PharmaShots

Ocugen Reports Preliminary Results from the P-I/II Trial of OCU400 for the Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis Date: Apr 14, 2023 | Tags: Ocugen, OCU400, Retinitis Pigmentosa, Leber Congenital Amaurosis, Clinical Trial, P-I/II Trial Candesant Biomedical Receives the US FDA Clearance of Brella SweatControl Patch for Primary (..)

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Blue Note leukaemia DTx gets FDA breakthrough tag

pharmaphorum

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. Breakthrough designations can speed up the development of new therapies, making them available to patients sooner.

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Pear claims breakthrough tag for alcohol use disorder DTx

pharmaphorum

Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorder. The post Pear claims breakthrough tag for alcohol use disorder DTx appeared first on. Photo by thom masat on Unsplash.

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Jab n Slim – Weight Loss in a Pen!

Fuld & Company Blog

In 2017, when semaglutide, the first long-acting GLP-1, was approved , it was a significant breakthrough. The real milestone was a year later in 2021 when Novo launched Wegovy , a rebranded version of Ozempic specifically designed, approved, and marketed for weight loss with double the weight loss potential of Saxenda.