Fda

• The FDA has granted a new indication for the drug Tzield, expanding its use to patients who have already progressed to Stage 3 type 1 diabetes. • This latest approval aims to preserve residual beta cell function, building on previous expansions in April 2026 that extended the drug's use to children as young as one year old. • The decision was based on the PROTECT trial, which demonstrated a statistically significant effect on C-peptide, a surrogate endpoint used to predict clinical benefit.

• The US Food and Drug Administration (FDA) is experiencing a period of instability characterized by the loss of thousands of employees through terminations or resignations. • The agency's accumulated expertise has been eroded, particularly within the drug and biologics centers, including the Center for Biologics Evaluation and Research. • This turmoil is attributed to politically appointed leadership, including Vinay Prasad, who have departed from the agency's traditional scientific norms for medical product reviews.

Moderna seeks FDA approval of its new shot, mFlusvia, as option for 50 and olderUS health advisers are debating a new kind of flu vaccine Thursday, the first made with the same mRNA technology that was key to ending the Covid-19 pandemic.Moderna is seeking Food and Drug Administration (FDA) approval of its new shot , dubbed mFlusiva, as an option for people 50 and older. The FDA advisory committee meeting is a step toward a final decision ahead of the winter flu season. Continue reading...

• In early 2026, the FDA implemented four strategic actions to modernize drug development, shifting focus toward flexibility and human-centric science. • The agency is prioritizing evidence quality and analytical sophistication over the sheer volume of data, acknowledging that advances in genomic medicine and biomarkers have outpaced old frameworks. • A key regulatory change allows for drug approval based on a single adequate and well-controlled trial, provided it is supported by sufficient confirmatory evidence.

• The FDA extended its review of a supplemental biologics license application (sBLA) submitted by Eisai and Biogen on May 8, 2026. • The application concerns a once-weekly subcutaneous autoinjector starting regimen for lecanemab-irmb (Leqembi Iqlik), used to treat early Alzheimer disease. • This regulatory delay pushes the Prescription Drug User Fee Act (PDUFA) action date to August 24, 2026.

• The FDA has officially approved the use of bemotrizinol, a highly effective sunscreen ingredient that has been widely utilized in European and Asian markets for years. • The decision follows long-term pressure from skincare advocates and sunscreen enthusiasts who pushed for the U.S. to adopt the ingredient to improve sun protection standards. • This move matters because bemotrizinol is known for its superior photostability and broad-spectrum coverage, offering better protection against UV rays than many current FDA-approved filters.

• The FDA has approved the oral antiviral ensitrelvir (Xocova), developed by Shionogi & Co, Ltd, for post-exposure prophylaxis (PEP) of COVID-19. • The treatment is authorized for use in adults and adolescents aged 12 years and older to prevent symptomatic SARS-CoV-2 infection. • Approval was based on the SCORPIO-PEP phase 3 trial, which demonstrated the drug's safety and efficacy in household contacts of symptomatic patients.