FDA
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
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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.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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On Feb. 15, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss an amended EUA for the Pfizer-BioNTech vaccine in the under 5 age group.
Ardelyx has reported in a regulatory filing that the FDA sent an Appeal Denied Letter for its drug tenapanor, a therapeutic intended for chronic kidney disease.
The FDA is slowing down the process of potentially approving dozens of new medications initially developed for the Chinese market.
An entire lot of the male erectile dysfunction drug The Red Pill is being pulled out of the market following the discovery that it contains some traces of tadalafil.
It’s not likely that the FDA will give the cancer drug sintilimab immediate attention, since the research was conducted exclusively in China.
The FDA’s decision is based on favorable results from Sanofi’s Phase III CARDINAL trial, a 26-week open label, single arm study on 24 CAD patients.
Gilead Sciences revealed in a call with analysts that the hold has now been expanded to additional magrolimab studies.
Recent FDA approval of ViiV Healthcare’s HIV treatment Cabenuva reduced dosing to once every two months.
Novavax is finally submitting an Emergency Use Authorization request to the U.S. Food and Drug Administration for its COVID-19 vaccine candidate, NVX-CoV2373, a protein-based vaccine.
The FDA’s decision is based on positive results from several Phase III studies, including the TENAYA and LUCERNE clinical trials.