- FDA Roundup: April 26, 2024on April 26, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 April 2024on April 26, 2024
CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for a vaccine that is effective…
- Confidentiality arrangement between the EU and the Republic of Koreaon April 26, 2024
This new partnership between the two regulatory authorities is an important step towards mutual recognition and regulatory harmonisation to improve human and animal…
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024on April 26, 2024
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.The CHMP recommended granting…, Positive recommendations on new medicines , […]
- FDA Approves New Treatment for Uncomplicated Urinary Tract Infectionson April 24, 2024
Today, the FDA approved a new treatment for female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
- FDA Roundup: April 23, 2024on April 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
- New recommendations to strengthen supply chains of critical medicineson April 23, 2024
These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which…
- FDA Roundup: April 19, 2024on April 19, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
- COVID-19 vaccine strain updates: Global regulators agree on timing and data requirementson April 17, 2024
International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine strain updates that was organised by the International Coalition…
- FDA Roundup: April 16, 2024on 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, 2024on April 12, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024on April 12, 2024
The PRAC has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) – dulaglutide, exenatide,…, Agenda Agenda of the PRAC meeting 8-11 April […]
- Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machineson 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, 2024on April 9, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
- EMA systems disruption expected from 11 to 17 Aprilon April 8, 2024
During this time, EMA will load nationally and centrally authorised product data to its Product Management Service (PMS) database. This is a crucial step in making structured and…
- FDA Roundup: April 5, 2024on 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 Useson 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 […]
- FDA Roundup: April 2, 2024on 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, 2024on 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, 2024on 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 Effectson 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 […]
- FDA Roundup: March 22, 2024on March 22, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.