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FDA Approval

Novavax Headquarters. © Getty Images
November 11, 2024

Novavax Receives FDA Approval to Resume Phase 3 Trials for COVID-19-Influenza Vaccine Following Clinical Hold Lift

FDA Approves Pfizer-BioNTech COVID-19 Vaccine
August 29, 2024

Precision Medicine Trailblazer Nuvectis Pharma Secures FDA Orphan Drug Designation for NXP800

The Orphan Drug Designation is more than just a regulatory milestone—it’s a strategic advantage that could dramatically reshape the future of Nuvectis Pharma.

FDA Approves Pfizer-BioNTech COVID-19 Vaccine
July 9, 2024

FDA Updates Guidance to Further Empower Companies to Address the Spread of Misinformation

FDA Approves Pfizer-BioNTech COVID-19 Vaccine
May 1, 2024

FDA to Hold Listening Session as Part of Broader Work to Optimize Use of, and Processes for, Advisory Committees

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US
March 7, 2024

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

No Industry Has Pre-Pandemic Employment Levels, Besides Federal Government
January 1, 2023

Congress Approves Landmark Measure to Reduce Animal Testing

No Industry Has Pre-Pandemic Employment Levels, Besides Federal Government
September 29, 2022

FDA Modernization Act Passes U.S. Senate, Premised on Achieving Major Reduction in Animal Testing

U.S. FDA Approves Nova Mentis Orphan Drug Application
September 6, 2022

U.S. Food and Drug Administration Awards $2.6 Million Orphan Products Development Grant

FDA Approves Pfizer-BioNTech COVID-19 Vaccine
September 1, 2022

FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

FDA Authorizes First COVID-19 Test Available Without a Prescription That Also Detects Flu and RSV
May 18, 2022

FDA Authorizes First COVID-19 Test Available Without a Prescription That Also Detects Flu and RSV

FDA Approves Alexion's Ultomiris for Treatment of gMG
May 1, 2022

FDA Approves Alexion’s Ultomiris for Treatment of gMG

Statement From FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments
April 10, 2022

Statement From FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments

Joint Statement with CMS Administrator Chiquita Brooks-LaSure

U.S. FDA Approves Nova Mentis Orphan Drug Application
February 13, 2022

FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 That Retains Activity Against Omicron Variant

FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses
December 10, 2021

FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses

The following is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, and Stic Harris, D.V.M. director of the FDA's Coordinated Outbreak Response and Evaluation Network

FDA Approves First Treatment for Common Type of Post-Transplant Infection That Is Resistant to Other Drugs
November 23, 2021

FDA Approves First Treatment for Common Type of Post-Transplant Infection That Is Resistant to Other Drugs

Approval is for cytomegalovirus, a type of herpes virus

FDA Approves Besremi to Treat Adults With Polycythemia Vera
November 13, 2021

FDA Approves Besremi to Treat Adults With Polycythemia Vera

The FDA granted the approval of Besremi to PharmaEssentia Corporation

U.S. FDA Approves Nova Mentis Orphan Drug Application
November 7, 2021

U.S. FDA Approves Nova Mentis Orphan Drug Application

FDA Approves Pfizer-BioNTech COVID-19 Vaccine
October 8, 2021

FDA Approves Innovative Treatment for Pediatric Patients With Congenital Athymia

Johnson & Johnson Submits Emergency Use Authorization Amendment to FDA to Support its COVID-19 Vaccine Booster
October 6, 2021

Johnson & Johnson Submits Emergency Use Authorization Amendment to FDA to Support its COVID-19 Vaccine Booster

FDA Will Follow the Science on COVID-19 Vaccines for Young Children
September 11, 2021

FDA Will Follow the Science on COVID-19 Vaccines for Young Children

FDA Approves Pfizer-BioNTech COVID-19 Vaccine
August 23, 2021

FDA Approves Pfizer-BioNTech COVID-19 Vaccine

TransMedics Announces Positive FDA Advisory Committee Vote for the OCS Liver System
July 15, 2021

TransMedics Announces Positive FDA Advisory Committee Vote for the OCS Liver System

FDA Approves Pfizer-BioNTech COVID-19 Vaccine
July 1, 2021

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

FDA Grants Accelerated Approval for Alzheimer’s Drug Aduhelm
June 7, 2021

FDA Grants Accelerated Approval for Alzheimer’s Drug Aduhelm

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Markets Herald W700Market Trends and Analysis • National Edition
  • Associated Press
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  • The Ritz Herald
  • Hudson Weekly
  • Madison Graph
  • Lincoln Citizen
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