Cancer centers in the U.S. are still grappling with shortages of critical drugs, according to a new survey by the National Comprehensive Cancer Network. Source: Drug Industry Daily
The FDA “remains unsatisfied” with Philips Respironics’ handling of the recall of its 15 million ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. Source:…
This year, those making combination products find themselves in a swirl of potentially confusing regulations and standards regarding risk management. Source: Drug Industry Daily
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation has released a report focusing on how the FDA can…
Amgen’s open-label confirmatory study of its lung cancer drug Lumakras (sotorasib) had too many data integrity problems to effectively show that the drug is an improvement over the standard-of-care chemotherapy…
Fourteen days of FDA inspection of its New Brunswick, N.J., facility in February and March earned Spectrum Laboratory Products a 483 describing yellow streaks on floors, peeling paint on walls…
Thirty-one organizations from across life sciences came together to oppose the FTC’s new approach to antitrust enforcement and launched the Partnership for the U.S. Life Science Ecosystem (PULSE), a new…
The issues the industry is grappling with these days dovetail perfectly with topics on tap at the GMP Quality Management Virtual Summit 2023 Oct. 11 and 12, according to Steve…
US WorldMeds got a 14-6 thumbs-up from FDA’s Oncologic Drugs Advisory Committee, supporting DFMO (difluoromethylornithine) to reduce the risk of relapse in children in remission after multifaceted treatment for high-risk…
A study published in JAMA showed that glucagon-like peptide 1 (GLP-1) agonists medications used for weight loss — Ozempic and Wegovy (both semaglutide) and Mounjaro (liraglutide) — come with increased risks…