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Month: July 2023

Limbix, a prescription PDTx company, acquired by Big Health
July 14, 2023 FDAcop

Limbix, a prescription PDTx company, acquired by Big Health

Big Health, a digital therapeutics company, has recently acquired Limbix, a maker of prescription digital therapeutics focused on treating depression in teenagers and young adults. Limbix has developed SparkRx, a self-guided cognitive behavioral therapy (CBT)-based treatment for depression in individuals aged 13 to 22. SparkRx was released in October 2021 and falls under the relaxed […]

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Two Biotechnology Companies Successfully Raise $385 Million in Combined IPOs, Breaking the Dry Spell
July 14, 2023 FDAcop

Two Biotechnology Companies Successfully Raise $385 Million in Combined IPOs, Breaking the Dry Spell

The IPO market has been slow this year, but Apogee Therapeutics and Sagimet Biosciences have managed to attract investor confidence and increase the size of their stock offerings. Apogee raised $300 million in its IPO and plans to stand out in the crowded field of immunology and inflammation drugs by offering a dosing advantage. The […]

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Perrigo’s Opill Becomes the First Oral Contraceptive to Switch to OTC Use with FDA Approval
July 14, 2023 FDAcop

Perrigo’s Opill Becomes the First Oral Contraceptive to Switch to OTC Use with FDA Approval

The FDA has approved the first over-the-counter oral contraceptive, making it more accessible and potentially reducing unintended pregnancies. The product, Opill, manufactured by HRA Pharma, will be available without a prescription in stores and online next year. Opill contains norgestrel, a synthetic hormone that suppresses ovulation. Despite being used safely for years, the drug should […]

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First Nonprescription Daily Oral Contraceptive Receives FDA Approval
July 13, 2023 FDAcop

First Nonprescription Daily Oral Contraceptive Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Opill, a non-prescription oral contraceptive tablet, for preventing pregnancy. This is the first daily oral contraceptive that can be purchased without a prescription in the United States. Opill will be available for sale at drug stores, convenience stores, grocery stores, and online, but the availability and […]

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Startup Français obtient 14 millions de dollars pour son outil d’intelligence artificielle d’échographie prénatale
July 13, 2023 FDAcop

Startup Français obtient 14 millions de dollars pour son outil d’intelligence artificielle d’échographie prénatale

French medical technology startup, Sonio, has raised $14 million in Series A funding, bringing its total funding to $20 million since its founding in 2020. Sonio’s AI platform automates ultrasound reporting, aiming to improve accuracy, speed, and efficiency for healthcare providers. The platform receives ultrasound images from any machine and processes them in the cloud […]

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Preparing for New Alzheimer’s Treatments: Three Essential Steps Health Systems Must Take
July 12, 2023 FDAcop

Preparing for New Alzheimer’s Treatments: Three Essential Steps Health Systems Must Take

The number of Americans affected by Alzheimer’s disease is on the rise, especially as Baby Boomers reach the age of 65. However, the lack of effective drug therapies and limited screening for cognitive decline have hindered a response to this public health crisis. Recently approved FDA drugs offer promising treatment options for Alzheimer’s, but they […]

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