The LIPFENDRA FDA approval makes Merck’s enlicitide the first once-daily oral PCSK9 inhibitor cleared to lower LDL-C in adults with hypercholesterolemia, including HeFH. Phase 3 CORALreef data showed placebo-adjusted LDL-C reductions of 56–59% at 24 weeks.
The FDA has approved PADCEV plus Keytruda as the first platinum-free neoadjuvant and adjuvant regimen for adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility, backed by Phase 3 EV-304 data showing major reductions in recurrence and death risk.
Merck has announced that the Phase 3 Trofuse-005 trial evaluating Sacituzumab Tirumotecan (Sac-TMT) successfully met its primary endpoints, offering a new hope for patients with advanced or metastatic NSCLC.
Merck receives Idvynso FDA approval for its once-daily single-tablet regimen of doravirine and islatravir. This breakthrough treatment offers a new option for adults living with HIV-1 who are virologically suppressed.
In a landmark development for personalized medicine, Moderna, Inc. and Merck (known as MSD outside the U.S. and Canada) announced today that their investigational mRNA-based [Read More…]
In a potentially practice-changing development for oncology, Merck announced that its Phase 3 KEYNOTE-B15 trial (also known as EV-304) has met its primary and key [Read More…]
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 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 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.
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.
