A key committee of the European Medicines Agency has recommended approval for an injectable version of Merck's cancer drug Keytruda, paving the way for potential authorization across the European Union. This subcutaneous formulation aims to offer a more convenient alternative to intravenous administration for patients with various cancers. The recommendation, issued on September 19, 2025, follows positive clinical data and could enhance treatment accessibility in Europe.

The U.S. Food and Drug Administration has granted approval for an injectable version of Merck's blockbuster cancer drug Keytruda, marking a significant advancement in treatment options for patients with certain types of cancer. This subcutaneous formulation promises greater convenience over the traditional intravenous method, potentially improving patient adherence and reducing healthcare burdens. The decision, announced on September 19, 2025, underscores ongoing innovations in oncology amid rising demands for more accessible therapies.

The U.S. Food and Drug Administration has approved Merck's Keytruda Qlex, a subcutaneous formulation of the cancer drug pembrolizumab, for use in adults across most solid tumor indications. Announced on September 19, 2025, this new injectable version offers a quicker administration time compared to the traditional intravenous method, potentially enhancing patient convenience and access to treatment. The approval highlights efforts to innovate drug delivery in oncology amid growing demands for efficient therapies.

The U.S. Food and Drug Administration has granted accelerated approval to Forzinity, the first treatment for Barth syndrome, a rare X-linked genetic disorder primarily affecting males. Developed by Stealth Biotherapeutics, the therapy targets mitochondrial dysfunction underlying the condition, offering new hope for patients with this life-threatening disease. This milestone follows years of advocacy and highlights progress in addressing ultra-rare disorders.

The PreCheck program was launched to boost domestic pharmaceutical manufacturing in the US. It focuses on increasing production capacity and supply chain resilience. Regulatory developments also include blood-based tests for Alzheimer's detection.