The European Medicines Agency (EMA) has welcomed a landmark political agreement on comprehensive reforms to EU pharmaceutical legislation. This modernization aims to streamline the development, authorization, and availability of medicines across the EU, significantly impacting patient access.

A NIH-led study identifies mobile DNA elements as potential biomarkers for aggressive lung cancer tumors through large-scale, multi-omics analysis. This discovery could pave the way for new diagnostic and therapeutic strategies in lung cancer management.

Today, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens.

EURORDIS applauds the final agreement on the EU Pharma Package, which reforms the General Pharmaceutical Legislation. This agreement is expected to enhance access to medicines for rare disease patients across the EU.

The proposed updates to the Increasing Organ Transplant Access (IOTA) Model aim to enhance organ transplant accessibility and improve performance metrics for Medicare. This initiative reflects ongoing efforts to optimize transplant programs and patient outcomes.

The FDA has issued a request for information regarding testosterone replacement therapy for men, seeking input from the public and stakeholders. This initiative aims to gather perspectives that will inform future regulatory considerations.

The CDC has opened a docket for public comment on its Draft Infection Control Guideline focusing on conjunctivitis among healthcare personnel. This update aims to enhance infection control measures based on the 1998 guidelines.

The CDC's rapid response has been crucial in addressing the first outbreak of infant botulism linked to formula, highlighting the importance of swift public health interventions. This investigation underscores the need for ongoing vigilance in food safety to protect vulnerable populations.

EURORDIS is actively shaping the development of the European Rare Disease Research Alliance (ERDERA), enhancing collaboration in rare disease research. This initiative aims to improve outcomes for patients by fostering partnerships across the rare disease community.

The FDA has released final guidance on promotional labeling and advertising for biological reference products, biosimilars, and interchangeable biosimilars. This guidance aims to clarify regulatory expectations for manufacturers and distributors in their promotional activities.

FDA has determined the regulatory review period for GRAFAPEX, which is necessary for a patent extension application. This notice is part of the legal requirements for patent claims related to human drug products.

FDA has determined the regulatory review period for FILSUVEZ, which is necessary for patent extension applications. This notice is part of the legal requirements for patent claims related to human drug products.

The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS).

The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program, marking the first approval achieved through this review pathway.

The EMA has released the second annual ESUAvet report, detailing antimicrobial sales and usage in veterinary medicine across the EU. The report emphasizes the importance of reliable data in promoting responsible use and improving public health outcomes.

The HHS is soliciting proposals for new and modified safe harbors and Special Fraud Alerts under the Federal anti-kickback statute. This annual notification invites recommendations that could impact compliance and regulatory frameworks in healthcare.

The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA).

Kim Isenberg has been appointed to the Board of Directors of the National Organization for Rare Disorders (NORD), enhancing the organization's leadership in patient advocacy. Her extensive experience in public affairs will support NORD's mission to improve the lives of those affected by rare diseases.

The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.