Last month brought pivotal FDA decisions that could shape the future of care in endocrinology and oncology. Two highly anticipated reviews—the approval of Crinetics Pharmaceuticals’ new oral treatment for acromegaly and the FDA’s decision on Merck’s subcutaneous formulation of Keytruda—captured the industry’s attention.
Crinetics Pharmaceuticals: Oral Acromegaly Treatment
On September 25, the FDA announced its decision on paltusotine, a once-daily oral therapy for acromegaly. If approved, it would mark only the second oral option available to patients, following Mycapssa (octreotide). Data from the Phase 3 PATHFNDR-1 and PATHFNDR-2 trials demonstrated paltusotine’s ability to effectively control insulin-like growth factor 1 (IGF-1) levels in both treatment-naive and previously treated adults. This development represents an important advancement for patients seeking more convenient and effective oral therapy options.
Merck: Subcutaneous Keytruda
Just days earlier, on September 23, the FDA decisions regarding subcutaneous Keytruda (pembrolizumab) made headlines. This new formulation offers patients a faster, more convenient alternative to the traditional intravenous administration. Phase 3 data showed that the subcutaneous injection, given every six weeks, achieved comparable pharmacokinetics to the IV version while reducing median injection time to just two minutes. For patients and providers, this innovation could mean shorter visits, improved comfort, and streamlined oncology care.
Implications for Pharmaceutical Distribution
These September approvals highlight the continued evolution of treatment options across therapeutic areas. For pharmaceutical distributors like Atlantic Biologicals, staying aligned with FDA developments ensures that providers gain timely access to the latest therapies. With new formulations and delivery methods emerging, understanding unique handling, administration, and storage requirements is essential to supporting safe and effective patient care.At Atlantic Biologicals, our products bring us together, our services set us apart. We remain committed to equipping healthcare partners with the most up-to-date solutions while delivering the highest standards of reliability and service.