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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 […]

FDA: Certain COVID-19 Serology/Antibody Tests Should Not Be Used

20/06/2020 MaP 0

Letter to Clinical Laboratory Staff and Health Care Providers The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop […]

FDA- Outbreak Investigation of Listeria monocytogenes: Enoki Mushrooms

09/06/2020 MaP 0

FDA’s investigation is complete. CDC declares outbreak over. The FDA, along with CDC and state and local partners investigated a multistate outbreak of Listeria monocytogenes […]

Roche’s Elecsys IL-6 test receives FDA Emergency Use Authorisation

07/06/2020 MaP 0

….to help in identifying patients at high risk of severe inflammatory response • FDA EUA1 now makes IL-6 testing accessible to patients in the United […]

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

20/05/2020 MaP 0

On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or […]

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

19/05/2020 MaP 0

Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors […]

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  • Pfizer and BioNTech Request Regulatory Agencies Expand Emergency Use of Their COVID-19 Vaccine to Adolescents
  • Spain – The vaccination schedule: when will we be vaccinated?
  • Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months
  • IPS Selected by Apiject as a Key Partner for Greenfield Blow−Fill−Seal Aseptic Manufacturing Campus
  • BioNTech provides Update on Vaccine Production Status at Marburg Manufacturing Site

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  • Pfizer and BioNTech Request Regulatory Agencies Expand Emergency Use of Their COVID-19 Vaccine to Adolescents

    09/04/2021 0
  • Spain – The vaccination schedule: when will we be vaccinated?

    07/04/2021 0
  • Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months

    01/04/2021 0
  • IPS Selected by Apiject as a Key Partner for Greenfield Blow−Fill−Seal Aseptic Manufacturing Campus

    30/03/2021 0
  • BioNTech provides Update on Vaccine Production Status at Marburg Manufacturing Site

    26/03/2021 0
Archives
  • April 2021 (3)
  • March 2021 (23)
  • February 2021 (22)
  • January 2021 (11)
  • December 2020 (29)
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