FDA
The agency flagged several violations at a compounding pharmacy owned by Hims & Hers, including “infestation by rodents, birds insects, and other vermin.”
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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 29, 2020.
The U.S. Food and Drug Administration has approved several drugs and medical devices in the last week. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 22, 2020.
Myovant’s oral Orgovyx beat out Abbvie’s injectable Lupron in achieving medical castration levels in patients. Here is the timeline of the approval.
The U.S. FDA is plenty busy with COVID-19 vaccine Emergency Use Authorizations this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Here’s a look.
It seems like history is repeating itself from just a week ago. Yesterday, the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency grant Moderna’s COVID-19 vaccine emergency use authorization (EUA).
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.