FDA
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease and type 2 diabetes.
Investigators found that the U.S. Food and Drug Administration is approving drugs faster than ever. Unfortunately, it appears that the agency is also approving those drugs on less data and weaker evidence.
What’s New at the J.P. Morgan Life Healthcare Conference?
Emma Walmsley, chief executive officer of GlaxoSmithKline, is predicting a good year for her company, with the potential of six regulatory approvals in the United States.
The first full business week of the new year began with plenty of clinical trial news. Here’s a look.
The State of California is considering a measure to sell its own brand of generic drugs in an effort to get in on those cost-savings. California’s Gov. Gavin Newsom is expected to reveal the scheme today in his new state budget.
Late Thursday, the U.S. Food and Drug Administration approved a new therapy to treat a rare mutation in patients with gastrointestinal stromal tumors.
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) continues moving toward the projections of becoming the world’s best-selling drug.
The company said Fiasp is the “first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.”
AstraZeneca and Merck are closing out 2019 on a high note with another approval for its PARP inhibitor Lynparza.