Food and Drug Administration (FDA)
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A recent study suggests that about one-third of cancer indications with Accelerated Approval pathways are still on product labels without follow-up studies confirming their benefits.
September is turning out to be a busy month for the U.S. Food and Drug Administration. Here’s a look at this week’s schedule for PDUFA dates.
Acorda Therapeutics is reducing its staff count by 15% effective immediately as it struggles to bring operating costs down and hit expected revenue.
Apellis Pharmaceuticals reported topline results from its Phase III DERBY and OAKS clinical trials for geographic atrophy secondary to age-related macular degeneration.
The FDA stated that it could not determine if the use of lenzilumab in COVID patients outweighs the known and potential safety risks.
The acquisition expands Sanofi’s General Medicines core assets and highlights the addition of Rezurock (belumosudil) to its transplant portfolio.
Heading into fall, with the COVID-19 pandemic surging again and researchers tracking new variants, there’s plenty of news. Here’s a look.
Gene therapy clinical trials have been paused due to safety concerns, including the most recent one by BioMarin Pharmaceutical.
The approval was built on data from the Phase III ASPEN trial that compared Brukinsa to ibrutinib in a total of 201 patients. Here’s more about the drug.
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