fda – pharma.markets

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older

03/01/2022 MaP 0

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 And BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age

17/12/2021 MaP 0

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 […]

Pfizer and BioNTech Submit Request to Amend U.S. FDA Emergency Use Authorization of Their COVID-19 Vaccine Booster to Include All Individuals 18 and Older

10/11/2021 MaP 0

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 […]

Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine

16/08/2021 MaP 0

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 and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine

07/05/2021 MaP 0

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 […]

FDA COVID-19 Alert: Beware of Misleading Registration Certificates

03/03/2021 MaP 0

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 […]

FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor

03/02/2021 MaP 0

….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 […]

Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies

02/12/2020 MaP 0

• 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 and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

20/11/2020 MaP 0

—————————————————————————————————————- 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) […]

Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients

08/09/2020 MaP 0

• Immunocompromised transplant patients are at risk of major complications when infected with BK virus • cobas BKV test addresses critical need for hospitals and […]

Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

04/09/2020 MaP 0

• First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single […]

Novartis Cosentyx® receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis

20/06/2020 MaP 0

• FDA approval for Cosentyx® is based on the Phase III PREVENT trial, demonstrating efficacy in active non-radiographic axial spondyloarthritis (nr-axSpA), which is part of […]