ACIP today voted to recommend individual-based decision-making for hepatitis B vaccine.

Original title: “ACIP Recommends Individual-Based Decision-Making for Hepatitis B Vaccine for Infants Born to Women Who Test Negative for the Virus”

The U.S. Food and Drug Administration (FDA) today announced that Tracy Beth Høeg, M.D., Ph.D., has been appointed acting director of the Center for Drug Evaluation and Research (CDER).

Original title: “FDA Announces Leadership Appointments at Center for Drug Evaluation and Research”

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.

Original title: “FDA Seizes 7-OH Opioids to Protect American Consumers”

Today, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.

Original title: “FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies”

The EveryLife Foundation for Rare Diseases applauds the House of Representatives for passing the Give Kids a Chance Act (H.R. 1262), legislation that includes policies that will spur progress in […] The post The EveryLife Foundation Applauds House Passage of the Give Kids a Chance Act appeared first on EveryLife Foundation for Rare Diseases.

Original title: “The EveryLife Foundation Applauds House Passage of the Give Kids a Chance Act”

The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees.

Original title: “FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment”

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

Original title: “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 November 2025”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 6226: Latino Youth Mental Health Empowerment Act”

Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 6167: HEALTH Act of 2025”

The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings.

Original title: “FDA Pilots Faster Clarifications to Meeting Minutes ”

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

Original title: “Improved scientific advice for medicines for public health threats including antimicrobial resistance”

On November 12, the President signed legislation to end the government shutdown, reopening the government to normal operations. The agreement includes a continuing resolution funding most of the government until […] The post The Government Reopens appeared first on EveryLife Foundation for Rare Diseases.

Original title: “The Government Reopens”

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.

Original title: “Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research”

The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health.

Original title: “HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy”

The coming months will be shape whether the EU's seven-year budget delivers for rare diseases. The post The EU’s 2028-34 budget: Improving the multiannual financial framework for people living with a rare disease  appeared first on EURORDIS-Rare Diseases Europe.

Original title: “The EU’s 2028-34 budget: Improving the multiannual financial framework for people living with a rare disease ”

The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox.

Original title: “FDA Warns Companies Over Illegal Marketing of Botox and Related Products”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 5925: HHS Reproductive and Sexual Health Ombuds Act of 2025”

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Financial Services, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 5859: Behavioral Health Crisis Care Centers Act of 2025”

Referred to the House Committee on Energy and Commerce.

Original title: “HRES 835: Declaring gun violence a public health crisis.”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 3038: Health Care Workforce Real-Time Data Dashboard Act”