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Second Booster Dose Authorized to Up Protection Against COVID-19 for Certain People
The Emergency Use Authorization was based on safety and immunogenicity data provided to the Agency.
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Famotidine Study Shows Some Benefit in Mild to Moderate COVID-19
The randomized, double-blind, placebo controlled, fully remote study was led by The Feinstein Institutes for Medical Research at Northwell Health and Cold Spring Harbor Laboratory.
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Contraindication Added to Janssen COVID-19 Vaccine Fact Sheet
Cases of TTS have been reported in both males and females.
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FDA Approves Urethral Stricture Treatment Optilume
The Optilume device includes a balloon coated with paclitaxel.
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Pfizer-BioNTech COVID-19 Booster Authorized for 16- and 17-Year-Olds
Individuals in this age group should only receive this vaccine as their booster.
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Early Data Suggest Potential Benefit of Heterologous Boosting for COVID-19
The independent study conducted by Dan Barouch, MD, PhD, et al of Beth Israel Deaconess Medical Center included a subset of participants from the COV2008 study.
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Study Investigates Rate of Antidrug Antibody Formation to Biologics Used in IBD
Given that immunogenicity to biologics may contribute to IBD treatment failure, the study authors sought to determine the rate of ADA formation to individual biologic agents.
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Fracture Risk Assessed Among Users of SGLT-2 Inhibitors vs Other Antidiabetic Agents
The study authors conducted a nationwide cohort study that included 137,667 Medicare beneficiaries.
Drugs in the Pipeline
FDA Panel Votes in Favor of Pfizer-BioNTech COVID-19 Vaccine for 5 to 11 Year-Olds
The panel reviewed safety and efficacy data from a phase 2/3 study that included 2268 participants who received a 2-dose regimen of 10mcg administered 21 days apart.
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CDC: Booster Recommendations Expanded to All Authorized COVID-19 Vaccines
The CDC recommendations also allow for the use of a heterologous (or “mix and match”) booster dose.
