FDA Roundup: May 7, 2024FDA Roundup: May 7, 2024 - FDA.gov fda.gov Submitted by fdagov3951 on May 8, 2024 at 4:00 AM in health No comments 16
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy - FDA.gov fda.gov Submitted by fdagov3951 on March 19, 2024 at 5:00 PM in business No comments 53
FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease - FDA.gov fda.gov Submitted by fdagov3951 on March 15, 2024 at 7:45 PM in business No comments 32
Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk - FDA.gov fda.gov Submitted by fdagov3951 on February 6, 2024 at 2:20 PM in business No comments 55
ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices - FDA.gov fda.gov Submitted by fdagov3951 on January 13, 2024 at 12:00 AM in business No comments 13
Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity - FDA.gov fda.gov Submitted by fdagov3951 on January 12, 2024 at 12:00 AM in business No comments 1
Joint Federal Operation Results in Seizure of More Than $18 Million in Illegal E-Cigarettes - FDA.gov fda.gov Submitted by fdagov3951 on December 15, 2023 at 3:30 PM in business No comments 46
FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease - FDA.gov fda.gov Submitted by fdagov3951 on December 9, 2023 at 4:00 PM in business No comments 15
FDA Cautions Public of Safety Issue with Philips' DreamStation 2 CPAP Machines - FDA.gov fda.gov Submitted by fdagov3951 on November 29, 2023 at 8:30 PM in business No comments 51
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors - FDA.gov fda.gov Submitted by fdagov3951 on November 28, 2023 at 10:30 PM in business No comments 4
CF Dallas, LLC, in Coordination with Sofia Produce, LLC Dba Trufresh, Voluntarily Recalls Select Fresh-Cut Fruit Products Due to Possible Salmonella Contamination - FDA.gov fda.gov Submitted by fdagov3951 on November 24, 2023 at 2:40 AM in business No comments 32
FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder - FDA.gov fda.gov Submitted by fdagov3951 on November 10, 2023 at 7:25 PM in business No comments 44
FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases - FDA.gov fda.gov Submitted by fdagov3951 on November 1, 2023 at 9:50 PM in business No comments 17
FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants - FDA.gov fda.gov Submitted by fdagov3951 on October 27, 2023 at 3:00 PM in business No comments 16
FDA Establishes New Advisory Committee on Digital Health Technologies - FDA.gov fda.gov Submitted by fdagov3951 on October 12, 2023 at 1:00 PM in business No comments 54
FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders - FDA.gov fda.gov Submitted by fdagov3951 on October 5, 2023 at 1:14 PM in health No comments 35
FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types - FDA.gov fda.gov Submitted by fdagov3951 on September 30, 2023 at 10:00 PM in health No comments 37
FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies - FDA.gov fda.gov Submitted by fdagov3951 on September 30, 2023 at 4:00 PM in business No comments 36
FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests - FDA.gov fda.gov Submitted by fdagov3951 on September 29, 2023 at 12:45 PM in business No comments 38
FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products | FDA - FDA.gov fda.gov Submitted by fdagov3951 on September 12, 2023 at 4:00 AM in business No comments 35
FDA Approves First Biosimilar to Treat Multiple Sclerosis - FDA.gov fda.gov Submitted by fdagov3951 on August 24, 2023 at 9:00 PM in business No comments 42
FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program - FDA.gov fda.gov Submitted by fdagov3951 on August 23, 2023 at 4:15 PM in business No comments 24
FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product - FDA.gov fda.gov Submitted by fdagov3951 on July 28, 2023 at 4:41 PM in health No comments 32
FDA Approves New Drug to Prevent RSV in Babies and Toddlers - FDA.gov fda.gov Submitted by fdagov3951 on July 17, 2023 at 4:34 PM in business No comments 14
FDA Approves First Nonprescription Daily Oral Contraceptive - FDA.gov fda.gov Submitted by fdagov3951 on July 13, 2023 at 11:30 AM in business No comments 10