U.S. FDA Approves PADCEV® and KEYTRUDA® Combo for Patients with Bladder Cancer

pfizer news

The FDA has granted approval for PADCEV® plus KEYTRUDA® as a perioperative treatment for cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). Clinical data reveals the combination reduces the risk of recurrence, progression, or death by 60% compared to surgery alone, marking a major shift in the standard of care.

Merck to Acquire Cidara Therapeutics for $9.2 Billion, Gaining Late-Stage Antiviral Agent CD388

Merck MSD

Merck has announced a definitive agreement to acquire Cidara Therapeutics for approximately $9.2 billion in an all-cash deal. The strategic acquisition centers on Cidara’s lead candidate, CD388, a potentially first-in-class, long-acting antiviral designed for the universal prevention of influenza A and B, which is currently in Phase 3 trials. The transaction is expected to close in the first quarter of 2026.

Merck’s Oral PCSK9 Inhibitor, Enlicitide, Shows Significant LDL-C Reduction in Phase 3 CORALreef HeFH Trial

Merck MSD

Merck announced promising results from its pivotal Phase 3 CORALreef HeFH trial. The study found that enlicitide, an investigational, once-daily oral PCSK9 inhibitor, significantly reduced low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH). These late-breaking data were presented at the AHA Scientific Sessions 2025.

Breakthrough in Bladder Cancer Treatment: PADCEV and KEYTRUDA Combination Significantly Improves Survival

pfizer news

A landmark clinical trial reveals a powerful new weapon against aggressive bladder cancer. The combination of PADCEV™ and KEYTRUDA®, administered before and after surgery, has been shown to significantly improve survival rates for patients with muscle-invasive bladder cancer who are ineligible for cisplatin chemotherapy. These groundbreaking results could establish a new standard of care, offering profound hope for a patient population with previously limited options.

U.S. FDA Approves Merck’s Keytruda Qlex, a Faster-Administered Subcutaneous Version of Keytruda for Cancer Treatment

Merck MSD

The U.S. Food and Drug Administration (FDA) has approved Merck’s Keytruda Qlex, a new subcutaneous formulation of its leading cancer immunotherapy drug. This game-changing approval introduces a fixed-dose combination of pembrolizumab and berahyaluronidase alfa-pmph, allowing the treatment to be administered as a simple injection in as little as one minute, a significant reduction from the previous 30-minute intravenous infusion. Approved for most of Keytruda’s existing solid tumor indications in adults, this new formulation was shown in clinical trials to have a comparable efficacy and safety profile to the IV version. The approval marks a major advancement in patient-centered care, offering a more convenient and less time-consuming option for thousands of cancer patients.