FDA Updates for the Week of March 7, 2022
March 12th 2022The agency plans to convene an advisory committee to review the application of Nuplazid to treat Alzheimer’s psychosis. The FDA also approved an indication for Opdivo, okays a third biosimilar to blockbuster cancer treatment Neupogen, and issues complete response letter for long-acting HIV therapy.
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The Pipeline is Full and Brimming with Promise. Hat Tip to Science.
January 6th 20222021 was a year in which investigators, government officials and drug companies overcame immense challenges to develop successful vaccines against COVID-19. That spirit of innovation is expected to carry over into this year.
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FDA Updates for the Week of December 6, 2021
December 11th 2021In COVID-19 news, FDA grants EUA to AstraZeneca’s monoclonal antibody to prevent infection and the FDA extends EUA of Pfizer/BioNTech Booster to those 16 and 17 years of age. The regulatory agency also approved a therapy for spasticity resulting from multiple sclerosis, and is requiring an updated boxed warning on three top-selling JAK inhibitors for rheumatoid arthritis. And FDA committee votes no on kidney disease drug.
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FDA Updates for Week of Nov. 29, 2021
December 4th 2021In COVID-19 news, an advisory committee recommends approval of oral antiviral after Merck releases updated data. The FDA made three approvals this week: an imaging agent to detect ovarian cancer and a vaccine for hepatitis B, and Darzalex Faspro is given an additional indication. New regulatory applications include: Lynparza for early breast cancer; the psoriasis therapy deucravacitinib, a pneumococcal vaccine for children, and an anemia therapy. The regulatory agency also paused the updated clozapine REMS program.
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