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 approval of HAnano Surface in the United States has been executed in accordance with the new 510(k) legislation for medical devices.
A look at the latest batch of FDA approvals this year.
This could be the first step in a long journey that could amount to huge profitability for the iPhone maker.
Foundation Medicine’s sequencing diagnostics test for solid tumors that can detect cancer-causing mutations in 324 genes was approved by the FDA Thursday.
HIV patients have a new maintenance drug in their arsenal of medication.
A look at the 19 spine-related medical devices the FDA cleared in October.
The FDA approved a label expansion for Pfizer’s cancer drug Sutent to include the adjuvant treatment of adult patients at high risk of RCC following the surgical removal of the cancerous kidney.
Genentech scored two approvals from the FDA this week.
The drug will be used to prevent or reduce the frequency of bleeding episodes in certain patients.
The FDA approved Dynavax’s Heplisav-B, it’s first new hepatitis B vaccine in the U.S. in more than 25 years.