Government
The U.S. Food and Drug Administration approved Janssen Pharmaceuticals’ Darzalex Faspro for adults with newly diagnosed light chain amyloidosis.
After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up. Here’s a look.
Although there are now two authorized vaccines against COVID-19 available in the United States and a third likely on the way with Johnson & Johnson’s candidate, the nation and world are nowhere near being done with the novel coronavirus, especially with new, more contagious variants now circulating.
The U.S. FDA approved Pfizer’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive.
In many regards, the incoming Biden Administration is expected to be a redux of the Obama Administration, likely with strong support for scientific research and a reinvigoration of the Affordable Care Act. Yet concerns of pricing controls still loom.
Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.
Merck announced the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for V114, its 15-valent pneumococcal conjugate vaccine, for Priority Review.
Slaoui will stay on as an adviser for one month. His resignation from the vaccine program was made at the request of the incoming Biden administration.
The U.S. Food and Drug Administration is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services, the department that oversees the agency and its operations.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 12, 2021.
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