We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
As COVID-19 drug shortages continue to plague the global supply chain, Sanofi’s arthritis drug Kevzara (sarilumab) has become the latest casualty. Read More
The FDA’s newly launched novel excipient review pilot program aims to identify possible safety issues before they can delay a drug’s application, said a senior official within the Center for Drug Evaluation and Research (CDER). Read More
More than two dozen advocacy groups have sent a letter to President Biden, urging him not to nominate Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization (BIO), for the role of FDA commissioner. Read More
Just two days in advance of an independent advisory committee meeting to discuss whether or not the FDA should grant Emergency Use Authorization (EUA) to Moderna’s COVID-19 booster shot, the FDA has released documents saying Moderna hadn’t met all of the agency’s criteria to support use of a booster. Read More
The companies are accused of failing to warn patients about the possible contamination of their ranitidine products with N-nitrosodimethylamine (NDMA). Read More
Holdouts among party centrists and warring legislation could derail Democrats’ efforts to include drug pricing reform in the $3.5 trillion Build Back Better Act — ahead of a self-imposed Oct. 31 deadline for passage. Read More
In its final guidance, NICE said the list price for Adakveo was confidential as was the discount the NHS would be receiving for offering the drug. Read More
A federal judge has ruled that he won’t dismiss class-action lawsuits against several brand-name drugmakers brought by consumers over the potentially contaminated heartburn drug Zantac (ranitidine). Read More
Amgen’s cancer drug Lumakras (sotorasib), developed to treat KRAS G12C-mutated tumors, has posted disappointing phase 1b study results when combined with other regimens. Read More
The FDA has found a small — but statistically significant — association between Guillain-Barre Syndrome (GBS) and Johnson & Johnson’s (J&J) COVID-19 vaccine, Ad26.COV2.S. Read More
In order to produce a high-quality lay summary, drug sponsors should adopt a four-step process: planning, development, translation and dissemination, the guidance recommends. Read More