COVID-19 Update

Combatting Future Viral Threats with Vaccine Advances

The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.

What’s Next for COVID-19 Vaccines and Variants?

More technologies and treatments are emerging for COVID-19—along with new variants.

Key Elements for Assay Transfer Success

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

FDA Approves Olumiant (baricitinib) to Treat COVID-19 in Hospitalized Adults

May 11, 2022

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

FDA Limits Use of Janssen COVID-19 Vaccine

May 06, 2022

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

FDA’s Office of Compliance Releases 2021 Annual Report

May 03, 2022

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

Moderna Submits EUA of COVID-19 Vaccine for Use in Young Children

May 02, 2022

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

FDA and Industry Prepare for Transition from Emergency Use Authorizations

May 02, 2022

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

Pfizer and BioNTech Submit EUA Application for Pediatric COVID-19 Vaccine Booster Dose

April 27, 2022

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

FDA Approves Veklury for Treatment of COVID-19 in Pediatric Patients

April 25, 2022

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

ReiThera and Exothera Collaborate on Manufacturing Vaccines for Low and Middle-income Countries

April 14, 2022

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine

April 13, 2022

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

University Hospital Hamburg-Eppendorf Leads Trial to Explore Personalized Medicine in COVID-19

April 12, 2022

Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine for treatment of COVID-19.