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.

KFF Health News briefings for September 15 and 16, 2025, cover key healthcare developments including policy changes, medical breakthroughs, and public health updates. The reports provide objective insights into U.S. health issues. They highlight ongoing debates on insurance and access.

Science news roundups from September 14-16, 2025, cover potential life on Mars, theoretical black hole stars, a global diabetes crisis, and miracle eye drops for vision restoration. The reports present consistent information across the sources without contradictions. These developments span space exploration and medical breakthroughs, informing the public on current scientific progress.

Recent medical marvels include advancements in gene editing and AI-driven diagnostics, promising to revolutionize healthcare delivery. Sources report on new treatments for chronic diseases, with some debates over ethical implications and accessibility. These developments were highlighted in science news summaries and health briefings.

India's CDSCO has approved a new trial for an autoimmune drug by Mankind Pharma, following successful multicentric trials for other medical devices. This development addresses rising needs for treatments amid increasing lifestyle disease deaths. The trial focuses on broad therapeutic applications for autoimmune conditions.

StemDAO is developing therapies using extracellular vesicles from stem cells to address soft tissue injuries, cognitive decline, and aging. Clinical data shows benefits in cognition, skin health, and inflammation reduction. This approach triggers natural regeneration without surgery.

Vaccine therapy for malignant glioma is advancing, with calls for expedited approvals to treat this aggressive brain cancer. The approach has potential to save lives and is part of efforts for rare disease treatments. Early results indicate effectiveness without traditional chemo or radiation.

The World Health Organization has updated its essential medicines list to include key diabetes treatments, improving access to innovative care. Advancements also feature AI-paired devices and smarter insulin systems for better management. These tools aim to enhance monitoring and delay onset in at-risk groups.

New gene therapies are in development for conditions like follistatin-related disorders and other genetic issues, aiming to provide effective treatments without ongoing interventions. The pipeline includes therapies for muscle growth, hormone regulation, and tissue repair. This marks progress in precision medicine for rare and chronic diseases.

A new treatment tested in brain organoids with glioblastoma outperformed chemotherapy and dramatically reduced tumors in mice. Human trials are upcoming. The approach also explores stem cell stimulation and aging cell rejuvenation for broader immunotherapy applications.

Stanford researchers have created a CRISPR-based technology to target RNA in neurons, enabling repair processes for genetic diseases. The method addresses key challenges in Cas9 delivery and DNA repair. It reveals unique genome editing rules in neurons, paving the way for targeted therapies.

Researchers have developed a pill that stimulates brain regeneration for stroke recovery by promoting neurogenesis and repairing damage. Tested in preclinical models, the drug replicates rehabilitation effects without extensive therapy. This innovation offers new hope for stroke patients worldwide.

A synthetic mRNA therapy successfully regenerated uterine lining in clinical trials, engineering pathways to restore ovarian function in aging populations, as reported on September 8, 2025.

Targeted nanomachines for clearing senescent cells in reproductive tissues, along with gene therapies for telomerase reactivation, were reported on September 11, 2025.

Recent developments in diabetes care include smarter insulin delivery systems and an AI-paired artificial pancreas, highlighted on September 11, 2025.

A new study showed quantum technology achieving 80% tumor shrinkage in brain cancer, published in The Lancet Oncology on September 11, 2025.

New human studies on transcranial focused ultrasound (tFUS) demonstrated its ability to alter perception, mood, and decision-making, with expansions reported on September 9, 2025.