FDA Approves First COVID-19 Vaccine

24-Aug-2021 - The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also ...

FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing

25-Mar-2020 - PerkinElmer, Inc. announced that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this kit ...

Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization

Test results in three and half hours

13-Mar-2020 - Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples ...

Merck and Pfizer receive FDA approval for kidney cancer therapy

BAVENCIO® (avelumab) plus Axitinib Combination for Patients with Advanced Renal Cell Carcinoma

15-May-2019 - Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a ...

FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of MS

01-Aug-2018 - Merck announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis (MS) has been accepted for filing by the U.S. Food and Drug Administration (FDA). “We are delighted the FDA has accepted ...

Do not try CRISPR at home

Urgent warning from FDA

13-Dec-2017 - Gene therapy is the administration of genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use. Gene therapies offer the potential to treat diseases or conditions for which no or few treatments exist. They ...

FDA approval brings first gene therapy to the United States

01-Sep-2017 - The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain ...

FDA Grants Approval for avelumab

First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma

24-Mar-2017 - Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). This indication is approved ...

FDA Accepts the Biologics License Application for Avelumab for Priority Review

Avelumab could be the first treatment indicated for patients with metastatic Merkel cell carcinoma

30-Nov-2016 - Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for avelumab, which was submitted by EMD Serono, the biopharmaceutical business of Merck in the US and Canada. This review relates to avelumab’s ...

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

21-Sep-2016 - The U.S. Food and Drug Administration approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, ...