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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
In late September, HRSA sent similar letters to six pharmaceutical companies — AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics. Read More
The FDA’s Antimicrobial Drugs Advisory Committee gave Takeda’s investigational antiviral, maribavir, a unanimous thumbs-up yesterday in two 17-0 votes as a potential treatment for refractory human cytomegalovirus (HCMV) infections in post-transplant patients with or without genotypic resistance. Read More
Pfizer and BioNTech have filed for FDA authorization of their COVID-19 vaccine for inoculating children aged five to 11 years and the agency’s vaccine advisory panel will take up the matter at its previously scheduled meeting on Oct. 26 to consider the request. Read More