Pharmacy

The FDA has published 17 revised draft product-specific guidances for peptide products, updating its recommendations for the development and assessment of certain generic peptide drugs. The revised draft guidances address the following peptide products, according to a July 28 agency…

Becker’s asked pharmacy executives from hospitals and health systems, along with academic medical centers and universities across the U.S. to share the biggest shifts they’re seeing in patient expectation. The 17 executives featured in this article are all speaking at…

The FDA approved Simtriyo (centanafadine), making it the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20 kilograms, according…

Betting platforms Kalshi and Polymarket are now taking wagers on whether the FDA will approve treatments for lung, breast, pancreatic and blood cancers this year, with Kalshi also planning to let users bet on clinical trial outcomes.     Kalshi launched the…

A federal court has denied North Dakota’s request to pause enforcement of a ruling that struck down its 340B drug pricing law while the state appeals, according to a July 27 court order. The U.S. District Court for the District…

An FDA advisory committee is scheduled to review Capricor Therapeutics’ cell therapy deramiocel after agency reviewers concluded the available clinical data do not provide substantial evidence that the treatment is effective for Duchenne muscular dystrophy. FDA reviewers said the phase…

Major Pharmaceuticals has recalled 12 levothyroxine sodium tablet products distributed nationwide after the FDA classified the action as a Class II recall because the medications were subpotent, according to a July 28 FDA enforcement report. The recall was initiated July…

CVS Health has moved to dismiss lawsuits brought by hospital systems in New York and Michigan alleging the company diverted 340B Drug Pricing Program savings. CVS argued in a July 22 Eastern District of Michigan filing that University of Michigan…

The FDA has approved Kenvue’s Tylenol with Naproxen, the first over-the-counter combination of 650-milligram acetaminophen and 220-milligram naproxen sodium. The product combines acetaminophen and naproxen sodium in a single over-the-counter formulation and was granted three years of exclusivity by the…

ADAP Advocacy has called for oversight of the 340B Drug Pricing Program to move from HRSA to CMS. The advocacy organization said the shift would address what it described as longstanding gaps in regulatory oversight and enforcement, according to a…