FDA & EMA - Pharminent

First report on EU-wide sales and use of antimicrobials in animals
on March 31, 2025
For the first time, all the 27 countries of the European Union (EU27) together with Iceland and Norway, have collected and reported data on both sales and use of antimicrobials in…
FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
on March 28, 2025
Today, the U.S. Food and Drug Administration approved a novel treatment for hemophilia A or B, with or without factor VIII or IX inhibitors (neutralizing antibodies).
FDA Roundup: March 28, 2025
on March 28, 2025
FDA Roundup: March 28, 2025
FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis
on March 28, 2025
The FDA granted marketing authorization of the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025
on March 28, 2025
Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2025 meeting.The committee recommended…, Positive recommendations on new medicines , Xoanacyl […]
EMA establishes regular procedure for scientific advice on certain high-risk medical devices
on March 24, 2025
On 24 March 2025, EMA updated this news announcement to include an interim report on the scientific advice pilot for high-risk medical devices. Find the report under ‘Related…
FDA Roundup: March 21, 2025
on March 21, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods
on March 20, 2025
Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the FDA unveiled a Chemical Contaminants Transparency Tool providing an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, […]
EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH) in biopsy samples
on March 20, 2025
EMA’s human medicines committee (CHMP) has issued the first Qualification Opinion (QO) on an innovative development methodology based on artificial intelligence (AI). The tool,…
FDA Roundup: March 18, 2025
on March 18, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families
on March 18, 2025
Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the FDA is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.
Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028
on March 18, 2025
EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS), following its recent adoption by the HMA and the…, “I am delighted to present our joint EMA / HMA network […]
FDA Roundup: March 14, 2025
on March 14, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette Use in One Year
on March 14, 2025
A study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth.
First vaccine against epizootic haemorrhagic disease recommended for approval
on March 14, 2025
EMA has recommended the approval of Hepizovac, the first vaccine against epizootic haemorrhagic disease (EHD) authorised in the EU for use in cattle. This new vaccine provides…
EMA Management Board: highlights of March 2025 meeting
on March 14, 2025
Election of new Management Board ChairAt its March meeting, EMA’s Management Bord elected Rui Santos Ivo as new chair of the Board for a three-year period. Mr Santos Ivo is…
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 March 2025
on March 14, 2025
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 10-13 March […]
Unregulated advanced therapy medicinal products pose serious risks to health
on March 13, 2025
EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the…, Important information for patients and their familiesThe products are […]
EMA Management Board elects new chair
on March 13, 2025
At its 13 March meeting, EMA’s Management Board elected Rui Santos Ivo as chair of the Board for a three-year period.Rui Santos Ivo takes over from Lorraine Nolan, Chief Executive…, Mr Santos Ivo is president of the Portuguese National Authority […]
FDA Roundup: March 11, 2025
on March 11, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: March 7, 2025
on March 7, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: March 4, 2025
on March 4, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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