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FDA Proposes Pediatric Labeling Changes for ADHD Drugs

The FDA has issued a proposal to update the pediatric labeling for certain Attention Deficit Hyperactivity Disorder (ADHD) drugs. This consultation seeks public comment on the proposed changes to ensure accurate and up-to-date information for healthcare providers and patients regarding the use of these medications in children.

FDA Complaint Document

The FDA has posted a complaint document related to FDA-2026-H-2387-0001. The document is authored by CTP and is available for download. This indicates a new enforcement action or investigation has been initiated.

FDA Complaint Document

The FDA has posted a complaint document related to enforcement actions. The document, authored by CTP, is available for review. Further details on the specific allegations and parties involved are not provided in the initial posting.

FDA Complaint Document

The FDA has posted a complaint document related to FDA-2026-H-2191-0001. This document is open for public comment, with a deadline for submissions.

Draft Labeling for Atomoxetine HCL Solution

The FDA has posted draft labeling for Atomoxetine HCL Solution for public comment. This document outlines proposed changes to the drug's labeling, which will impact manufacturers and potentially healthcare providers.

FDA Complaint for Public Comment

The FDA has posted a complaint for public comment, with the comment period closing on March 13, 2026. The complaint was authored by the CTP and is available for download.

FDA Approves Wellcovorin for Cerebral Folate Deficiency

The FDA has approved Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed FOLR1 gene variant. This marks the first FDA-approved treatment for this rare genetic condition.

FDA Approves Tec-Dara for Relapsed Multiple Myeloma

The FDA has approved Tec-Dara (teclistamab and daratumumab hyaluronidase-fihj) for relapsed or refractory multiple myeloma. This approval was granted under the Commissioner's National Priority Voucher (CNPV) pilot program, marking a significant acceleration in the review process.

FDA Launches Unified Adverse Event Analysis Platform AEMS

The FDA has launched a new unified platform, the Adverse Event Monitoring System (AEMS), to analyze adverse event reports for all regulated products. This modernization aims to improve data accessibility, transparency, and surveillance capabilities, replacing fragmented legacy systems and is expected to save $120 million over five years.

FDA Streamlines Biosimilar Development Guidance

The FDA issued draft guidance to streamline biosimilar development by recommending the reduction of unnecessary clinical pharmacokinetic testing when scientifically justified. This initiative aims to save developers up to 50% in PK study costs, potentially lowering drug prices and increasing patient access to affordable biologic treatments.