FDAgpt Archives - Page 36 of 41

July 17, 2023 Artificial Intelligence FDAcop

New Drug Granted FDA Approval for RSV Prevention in Infants and Young Children

The US Food and Drug Administration (FDA) has approved Beyfortus (nirsevimab-alip) as a preventive treatment for Respiratory Syncytial Virus (RSV) lower respiratory tract disease. This approval applies to neonates and infants born or entering their first RSV season, as well as children up to 24 months of age who are vulnerable to severe RSV disease […]

July 16, 2023 Artificial Intelligence FDAcop

Medicare Part D Spending in 2021: 22% Devoted to 10 Prescription Drugs, Report Finds

A new analysis by the Kaiser Family Foundation (KFF) has revealed that despite comprising only 0.3% of total covered drugs, the top 10 best-selling Medicare Part D drugs accounted for 22% of total gross Medicare drug spending in 2021. The findings offer important context for understanding the potential impact of the Medicare Drug Price Negotiation […]

July 15, 2023 Artificial Intelligence FDAcop

Making Effective Alternatives a Larger Focus in the CPAP Recall Narrative

The United States is currently facing a sleep crisis, with over one-third of American adults not getting enough sleep each night. This crisis has been worsened by the recall of millions of Continuous Positive Airway Pressure (CPAP) devices, which are commonly used to treat a serious condition called Obstructive Sleep Apnea (OSA). The recall was […]

July 15, 2023 Artificial Intelligence FDAcop

Gratitude Expressed: Life Sciences Analysis

As of FY2023, the FDA has five user fee programs that apply to its life sciences portfolio: PDUFA, MDUFA, GDUFA, BsUFA, and OMUFA. These programs require the FDA to develop new guidance documents, launch pilot programs, deploy technology systems, and hire new staff. The FDA has more than 300 tasks to complete during the authorization […]

July 15, 2023 Artificial Intelligence FDAcop

FDA Updates: July 14, 2023

The U.S. Food and Drug Administration (FDA) has provided a summary of recent news and updates from the agency. On Thursday, the FDA re-issued two temporary guidances that were originally published during the COVID-19 pandemic for certain regulatory requirements involving onsite visits abroad under the FDA Food Safety Modernization Act (FSMA). These guidances aim to […]

July 14, 2023 Artificial Intelligence 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 […]

July 14, 2023 Artificial Intelligence 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 […]

July 14, 2023 Artificial Intelligence FDAcop

Analysis of Life Sciences by Exclusive Regulatory Experts

The FDA, or Food and Drug Administration, has been implementing user fee programs since the passage of the FDA User Fee Reauthorization Act of 2023. These programs include PDUFA for prescription drugs and certain biologics, MDUFA for medical devices, GDUFA for generics, BsUFA for biosimilars, and OMUFA for over-the-counter monograph products. In order to determine […]

July 14, 2023 Artificial Intelligence 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 […]

July 14, 2023 Artificial Intelligence FDAcop

Article Exclusively Expressing Gratitude

The health subcommittee of the House Energy and Commerce (E&C) Committee will be holding a markup this week for the proposed reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), now known as the Preparing for All Hazards and Pathogens Reauthorization Act. However, the Food and Drug Administration (FDA) will not have any of its […]

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