FDA Roundup: April 19, 2024
Friday, April 19, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Roundup: April 16, 2024
Tuesday, April 16, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Roundup: April 12, 2024
Friday, April 12, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines
Tuesday, April 9, 2024
The federal court entered a consent decree of permanent injunction against Philips Respironics following a recall of certain sleep therapy machines manufactured by the company.

FDA Roundup: April 9, 2024
Tuesday, April 9, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Roundup: April 5, 2024
Friday, April 5, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Approves New Antibiotic for Three Different Uses
Wednesday, April 3, 2024
The FDA approved a new antibiotic for the treatment of certain patients with Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis; acute bacterial skin and skin structure infections; and community-acquired bacterial pneumonia.

FDA Roundup: April 2, 2024
Tuesday, April 2, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Roundup: March 29, 2024
Friday, March 29, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Roundup: March 26, 2024
Tuesday, March 26, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects
Tuesday, March 26, 2024
FDA warns consumers not to use certain over-the-counter pain relief products containing lidocaine that are marketed for topical use in cosmetic procedures like microdermabrasion, laser hair removal, tattooing and piercing, and issued warning letters to six companies for violating of federal law.

FDA Roundup: March 22, 2024
Friday, March 22, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Thursday, March 21, 2024
The FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD.

FDA Roundup: March 19, 2024
Tuesday, March 19, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
Monday, March 18, 2024
Lenmeldy is the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD).

FDA Roundup: March 15, 2024
Friday, March 15, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease
Thursday, March 14, 2024
The FDA approved the first medication for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring, to be used along with diet and exercise.

FDA Roundup: March 12, 2024
Tuesday, March 12, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health
Monday, March 11, 2024
FDA seeks $7.2 Billion to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure, buildings, and facilities

FDA Roundup: March 8, 2024
Friday, March 8, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.