- Regulatory information – adjusted fees for applications to EMA from 1 April 2024on March 27, 2024
The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will…
- 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 […]
- EMA business hours over Easter holiday periodon March 26, 2024
Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should…
- EU recommendations for 2024/2025 seasonal flu vaccine compositionon March 26, 2024
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024.…
- 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.
- EMA Management Board: highlights of March 2024 meetingon March 22, 2024
EMA annual report 2023 The Board adopted EMA’s annual report for 2023. In 2023, EMA recommended 77 medicines for marketing authorisation for human use, 39 of which had a new…
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024on March 22, 2024
12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.The CHMP recommended granting a…, Positive recommendations on new medicines , […]
- FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophyon 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.
- Accelerating stakeholder collaboration to enhance the clinical trials environment in the EUon March 20, 2024
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the…, The establishment of the multi-stakeholder platform is an […]
- FDA Roundup: March 19, 2024on 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 Leukodystrophyon 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).
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-13 March 2024on March 18, 2024
CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation for Divence Tetra from Laboratorios Hipra,…
- FDA Roundup: March 15, 2024on 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 Diseaseon 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, 2024on 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 Healthon 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, […]
- FDA Roundup: March 8, 2024on March 8, 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 to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweighton March 8, 2024
The FDA approved a new use for a drug to reduce the risk of cardiovascular disease, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024on March 8, 2024
EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases…, Agenda Agenda of the PRAC meeting 4-7 March […]
- FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the USon March 6, 2024
FDA takes additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children.
- DARWIN EU® continues expanding its capacity to deliver real-world data studieson March 6, 2024
The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to add ten new data…