FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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The U.S. Food and Drug Administration has four distinct approaches to speeding the drug approval process. Several of today’s announcements had one or more of these designations.
Bamlanivimab, an intravenous treatment, should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 10, 2020.
Here’s a look at some of the upcoming target action dates on the U.S. FDA’s calendar.
The latest approval for Brilinta is based on the Phase III THALES trial that showed aspirin plus 90 mg of Brilinta significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischemic stroke or TIA.
While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 3, 2020.
EYSUVIS is the first FDA-approved ocular corticosteroid for the treatment of dry eye disease. Know more about how it got approval and the complete development timeline here.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 27, 2020.
After discovering promising indicators on the path to the development of Branaplam (LMIO70) for spinal muscular atrophy, Novartis now hopes to repurpose the drug for the treatment of Hungtington’s disease.