PTC Therapeutics is awaiting the FDA decision for ataluren for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). The FDA granted ataluren Fast Track and Orphan Drug...

Your monthly synopsis of new drugs expected to hit the market At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade...

None Trending Topics New drugs July 11, 2025 – finerenone (Kerendia) Bayer; non-steroidal mineralocorticoid receptor antagonist (MRA); first MRA FDA-approved for heart failure (HF) with left...

Merck submitted a combination product containing pembrolizumab and berahyaluronidase alfa as a subcutaneous (SC) version of pembrolizumab (Keytruda) for approval across all previously approved...

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

Plozasiran, by Arrowhead, is a first-in-class RNA interference (RNAi) therapeutic designed to reduce production of apolipoprotein C-III (APOC3), thereby reducing circulating triglycerides (TG). It...

Prime’s industry-leading research on GLP-1s was recognized at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting in Houston

Merck submitted clesrovimab to the FDA for respiratory syncytial virus (RSV) disease prevention in infants during their first RSV season. If approved, clesrovimab will be the third monoclonal...