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The U.S. Food and Drug Administration today granted approval for Avance (acellular nerve allograft-arwx) in surgical implantation.
The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri.
Today, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.
The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees.
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 24 - 27 November 2025Draft…, PRAC statistics: December 2025 , PRAC statistics: December 2025 E
The post AFM-Téléthon 2025 appeared first on EURORDIS-Rare Diseases Europe.
The post ERN ReCONNET: Sharing Good Clinical Practice 2025 Event appeared first on EURORDIS-Rare Diseases Europe.
The post Patient Partnership Webinar: The UnDiagnosed Patients Working Group by ERN LUNG appeared first on EURORDIS-Rare Diseases Europe.
Updated on 27 November 2025: To extend the deadline for submissions of applications from 23 November to 5 December 2025 , The European Commission has launched a call for expressions of interest to represent patient and healthcare professional organisations in EMA’s Paediatric Committee (PDCO).…
The post European Conference on Rare Diseases and Orphan Products 2026 appeared first on EURORDIS-Rare Diseases Europe.
The U.S. Food and Drug Administration today approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in the survival motor neuron 1 (SMN1) gene.
This news announcement was updated on 20 November 2025 to correct the list of frequently reported adverse reactions. , EMA has recommended granting a marketing authorisation in the European Union (EU) for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and…
The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings.
EMA’s Emergency Task Force (ETF) is improving its approach to scientific advice for the most promising medicines and vaccines under development for public health threats.Under…, “With this new approach, developers will receive clear input on the design of clinical trials to allow generation of adequate evidence, and how these trials should be…, The approach will be crucial to enhance the rapid development and approval of medicines ahead of and during public health emergencies. The over
The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of th
Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its November 2025 meeting.The committee recommended…, CHMP statistics , CHMP statistics:…, Positive recommendations on new medicines, Dawnzera International non-proprietary name (INN) doni
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA.
The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health.
The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program.