Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age […]
… For Adolescents 12 through 15 Years of Age COMIRNATY® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 […]
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety […]
The Office of the U.S. Trade Representative (USTR) announced on Friday, February 4, 2022, that the United States and the European Union (EU) have concluded […]
With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy […]
First emergency use authorization in the United States for a COVID-19 vaccine booster in adolescents 12 through 15 years of age Today’s FDA action also […]
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and […]
Submission is based on efficacy and safety data from a Phase 3 randomized, controlled trial with more than 10,000 participants Data show a favorable safety […]
Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust […]
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug […]
How to tell if a device is approved, cleared, or authorized by the FDA During the COVID-19 pandemic, some companies are selling medical devices (including […]
….for Patients with Metastatic NSCLC with METex14 Skipping Alterations Merck today announced that the US Food and Drug Administration (FDA) has approved TEPMETKO® (tepotinib) following […]
• Elecsys® Anti-SARS-CoV-2 S test specifically detects antibodies against the SARS-CoV-2 spike protein • The spike protein is the target of many COVID-19 vaccines in […]
—————————————————————————————————————- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) […]
• Immunocompromised transplant patients are at risk of major complications when infected with BK virus • cobas BKV test addresses critical need for hospitals and […]
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