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Published on May 28, 2024 - 22:27 GMT

FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

For Immediate Release: May 28, 2024 Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 28, 2024 - 20:18 GMT

FDA Roundup: May 28, 2024

For Immediate Release: May 28, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA announced it had opened a new period for applications for grants to support the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 24, 2024 - 19:36 GMT

FDA Roundup: May 24, 2024

For Immediate Release: May 24, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA announced that Medline Industries, LP, a firm marketing and distributing plastic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 21, 2024 - 20:55 GMT

FDA Roundup: May 21, 2024

For Immediate Release: May 21, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced that registration is open for the two-day virtual public meeting, "FDA’s …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 17, 2024 - 20:01 GMT

FDA Roundup: May 17, 2024

For Immediate Release: May 17, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2024 - 18:02 GMT

FDA Roundup: May 14, 2024

For Immediate Release: May 14, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA’s Office of Science and Engineering Laboratories launched an improved online Regulatory …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 11, 2024 - 17:29 GMT

FDA Roundup: November 5, 2024

For Immediate Release: November 05, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published “Catching Up with Califf: One Health - Optimal Public Health Outcomes for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 10, 2024 - 20:13 GMT

FDA Roundup: May 10, 2024

For Immediate Release: May 10, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2024 - 14:15 GMT

FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair

For Immediate Release: May 09, 2024 Today, the U.S. Food and Drug Administration issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2024 - 13:34 GMT

Youth E-Cigarette Use Drops to Lowest Level in a Decade

For Immediate Release: September 05, 2024 Half a million fewer U.S. youth reported current use of e-cigarettes in 2024 compared to 2023, according to new data from the National Youth Tobacco Survey (NYTS) released today by the U.S. Food and Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 8, 2024 - 18:51 GMT

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

For Immediate Release: May 08, 2024 In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency (EPA), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 7, 2024 - 20:30 GMT

FDA Roundup: May 7, 2024

For Immediate Release: May 07, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee on June 4 to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 7, 2024 - 16:35 GMT

FDA Roundup: July 5, 2024

For Immediate Release: July 05, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA updated the advisory for the investigation of Salmonella illnesses linked to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2024 - 19:58 GMT

FDA Roundup: April 30, 2024

For Immediate Release: April 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 29, 2024 - 15:23 GMT

FDA to Hold Listening Session as Part of Broader Work to Optimize Use of, and Processes for, Advisory Committees

FDA News Release Public Engagement Critical to Further Enhance Input from External Expert Panels For Immediate Release: April 29, 2024 Today, the U.S. Food and Drug Administration announced it will host a listening session in June as part of its broader …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 29, 2024 - 14:18 GMT

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests

For Immediate Release: April 29, 2024 Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 26, 2024 - 19:25 GMT

FDA Roundup: April 26, 2024

For Immediate Release: April 26, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and …

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Published on April 24, 2024 - 18:38 GMT

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

For Immediate Release: April 24, 2024 Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia …

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Published on April 23, 2024 - 19:29 GMT

FDA Roundup: April 23, 2024

For Immediate Release: April 23, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a new initiative aimed to help reimagine the home environment as an integral …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 19, 2024 - 20:30 GMT

FDA Roundup: April 19, 2024

For Immediate Release: April 19, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA posted a safety communication to inform the public and healthcare providers that …

Distribution channels: Healthcare & Pharmaceuticals Industry