The FDA has appointed Richard Pazdur, MD, as director of the Center for Drug Evaluation and Research, effective Nov. 11. The center regulates prescription, over-the-counter and generic drugs, and oversees their development, approval and labeling. Dr. Pazdur, a 26-year FDA…

VCU Health, a three-hospital system based in Richmond, Va., will expand free home delivery services to all of its pharmacies Nov. 11.  The system operates seven pharmacies, according to a Nov. 6 news release. Individuals who are not a VCU…

HHS and the FDA are taking formal steps to remove boxed warnings from hormone replacement therapy products used to treat menopausal symptoms. The FDA began the process after reviewing updated scientific literature, convening an expert panel in July and opening…

The federal government’s recently approved 340B rebate pilot could reshape one of hospitals’ most relied-on drug discount programs, replacing upfront savings with delayed reimbursements and forcing covered entities to shoulder new financial and administrative risks. As the Jan. 1 start…

Fresenius Kabi USA is voluntarily recalling three lots of famotidine injection vials due to out-of-specification endotoxin results.  Famotidine injection is approved for some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, according to a Nov. 7 FDA recall alert.…

In the closing months of 2025, President Donald Trump’s effort to reshape how Americans pay for prescription drugs has taken clearer form. What started as a campaign threat to slap tariffs on pharmaceutical imports has evolved into a series of…

Pfizer has agreed to acquire weight-loss drugmaker Metsera in a transaction that could exceed $10 billion. Under the terms of the cash deal, Pfizer will pay $65.60 a share upfront, along with a contingent value right worth up to $20.65…

Intellia Therapeutics temporarily paused dosing and screening for its phase 3 Magnitude and Magnitude-2 trials of Nex-z following a patient hospitalization, according to an Oct. 27 news release. The patient, who had been hospitalized with severe liver-related side effects, has…

Mark Cuban Cost Plus Drug Co. has added Starjemza, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab), to its portfolio.  The company, co-founded by billionaire entrepreneur Mark Cuban, is offering two strengths of the biosimilar at $360 per syringe, plus…

A new analysis has raised concerns about the Cigna Group’s drug pricing strategy, finding that one of its subsidiaries, Quallent Pharmaceuticals, often charges more for generic medications than competing suppliers, according to a Nov. 7 report from Bloomberg. The review…