FDA Declines EUA Request for Fluvoxamine for COVID-19 Treatment
The totality of the evidence led the FDA to determine that the criteria for issuing an EUA had not been met.
All articles by Brian Park, PharmD
FDA Authorizes Direct-to-Consumer Test to Detect COVID-19, Influenza, and RSV
The test is the first non-prescription multi-analyte COVID-19 test that allows individuals to test nasal swab samples self-collected at home.
Remdesivir Injection Approval Expanded to Include COVID-19 Treatment in Younger Children
The approval was supported by data from a phase 2/3 CARAVAN study.
Warning Letters Sent to Online Pharmacies Illegally Selling Schedule II Stimulants
The FDA urges consumers to buy prescription drugs, such as Adderall, from state-licensed US pharmacies or physicians located in the US.
Baricitinib Approved for COVID-19 Treatment in Hospitalized Adults
The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
USPSTF Issues Recommendations on Aspirin Use to Prevent Cardiovascular Disease
These recommendations only apply to individuals who do not have a history of CVD and are not already taking daily aspirin.
FDA Authorizes Shelf-Life Extension for Certain COVID-19 Vaccines
The FDA has extended shelf-life for the Janssen COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine following a thorough review of data submitted by both manufacturers.
FDA Develops Plan to Improve Clinical Trial Diversity
The guidance aims to ensure that the data submitted to the Agency adequately represent the patients that will use the medical products.
Dupilumab Gets Priority Review for Eosinophilic Esophagitis in Children Aged 12 Years and Older
Dupilumab is an interleukin-4 receptor alpha antagonist.
Tenapanor Now Available for Irritable Bowel Syndrome With Constipation
The approval was based on two phase 3 trials which evaluated Ibsrela in over 1200 adults with IBS-C.
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