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 (FDA) had several approvals this week. Read on to see what the regulatory agency gave the go-ahead to.
The U.S. Food and Drug Administration has authorized the first non-prescription, over-the-counter, at-home antigen test that can be used to identify infection with SARS-CoV-2, the virus responsible for COVID-19, in people two years of age or older.
All eyes are turning to Moderna, which has a meeting with the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. The agency released the data application today.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 15, 2020.
The U.S. Food and Drug Administration (FDA), a day after a positive advisory committee recommendation, granted an Emergency Use Authorization (EUA) to Pfizer and BioNTech for their COVID-19 vaccine. Dosing is expected to begin in days.
All eyes on the FDA as they review a COVID-19 vaccine, FDA approval of an Emergency Use Authorization to LabCorp’s home test kit for COVID-19, the first testing device that does not require a prescription and more news.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 8, 2020.
Biopharma companies who have COVID-19 vaccines in development, have astonished skeptics by the speed with which they have developed vaccines.. But now comes an even more daunting challenge—scaling up manufacturing and distribution.
BioCryst Pharmaceuticals, Inc. announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and young patients 12 years and older.
The U.S. Food and Drug Administration has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood.