FDA
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.
FEATURED STORIES
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.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
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.
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.