fda – pharma.markets

Roche Alzheimer’s disease Cerebrospinal Fluid (CSF) assays receive FDA clearance, supporting more accurate and timely diagnosis

08/12/2022 MaP 0

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays have received […]

25/10/2022 MaP 0

MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval Following our communication last week “MedAlliance to be acquired by Cordis”, MedAlliance is pleased to make […]

Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems

24/10/2022 MaP 0

The cobas SARS-CoV-2 Qualitative test is one of the first COVID-19 PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance. […]

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine

22/08/2022 MaP 0

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 […]

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY®

08/07/2022 MaP 0

… 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 […]

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

17/06/2022 MaP 0

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 […]

Bilateral trade in bivalve molluscan shellfish to resume between the U.S. and the EU

08/02/2022 MaP 0

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 […]

Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA

01/02/2022 MaP 0

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 […]

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 […]