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Labeling for CBER-Regulated ProductsLabeling for CBER-Regulated Products
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SPIKEVAX
COVID19 Vaccine, mRNA
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Pfizer-BioNTech COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) Authorized For Individuals 6 Months through 11 Years of Age
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Moderna COVID-19 Vaccine
Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.
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COMIRNATY
COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
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FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination
FDA has required and approved updates to the Prescribing Information for Comirnaty manufactured by Pfizer Inc. and Spikevax manufactured ModernaTX, Inc. to include new safety information about the risks…
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John Casani, Former Manager of Multiple NASA Missions, DiesWith Voyager 2 in the background, John Casani holds a small U.S. flag that was sewn into the spacecraft’s thermal blankets before its 1977 launch.…
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NASA’s Perseverance Rover Scours Mars for Science
On June 3, NASA’s Perseverance Mars rover ground down a portion of a rock surface, blew away the resulting debris, and then went to work…
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FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS
Since approval, the FDA has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male patients with DDMD with ELEVIDYS, an adeno-associated virus vector-based gene therapy.
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What RFK Jr. Isn’t Talking About: How To Make Vaccines SaferWithin an hour of receiving a covid vaccination in November 2020, Utah preschool teacher Brianne Dressen felt pins and needles through her arms and legs.…
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