FDA Updates for Week of October 18, 2021
October 23rd 2021In COVID-19 news, the FDA issues EUA for both Moderna’s and J&J’s COVID-19 booster. In new drug approvals, there is a novel therapy for macular degeneration, new therapies for eye disease and opioid overdose, as well as new therapies for asthma and HIV in children.
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FDA Updates for the Week of October 11, 2021
October 16th 2021In COVID-19 news: An advisory committee recommends both J&J's and Moderna’s booster, Regeneron seeks full approved for its treatment and Merck seeks EUA for treatment. In cancer, the FDA approves Verzenio for early breast cancer, Keytruda for advanced cervical cancer, and Tecentriq in early nonsmall cell lung cancer.
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Study Looks At Novel Administration of Spinraza
October 14th 2021A new method for delivering this treatment drug for spinal muscular atrophy offers an option for patients with advanced cases of the disease. But investigators found that the new method may also carry risks of mechanical failure and infection.
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FDA Updates for the Week of Oct. 4, 2021
October 9th 2021Pfizer officially seeks EUA for pediatric COVID vaccine, AstraZeneca seeks EU for COVID-19 prevention, J&J submits data for COVID-19 booster, a gene therapy is approved for leukemia, and Janssen submits Stelara for psoriatic arthritis in children.
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FDA Requires New Labeling for Antidepressants
October 4th 2021The labeling for selective serotonin reuptake inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs) now must include information about sexual side effects in the warning and precautions and patient counseling sections.
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FDA News for the Week of Sept. 27, 2021
October 2nd 2021Approvals include a therapy for a rare disease for children and a novel migraine prevention. New regulatory applications include Biogen’s second Alzheimer’s therapy and other indications for Opdivo and Erbitux, and Pfizer submits data for COVID-19 vaccine for children.
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Study: Medication Management Leads to Big Savings
October 1st 2021Comprehensive medication management aided by AI clinical decision support can result in a large return on investment in a high-risk population. In this study, every dollar that was invested resulted in $12 in savings or cost avoidance.
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