Archive for June, 2021

FDA Provides Update on Ongoing Efforts to Better Understand the Occurrence of PFAS in the Food Supply

Today, the U.S. Food and Drug Administration is providing an update on its ongoing sampling and testing efforts designed to better understand the occurrence of…

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

Today, the U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia…

FDA In Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide

The following quote is attributed to Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for…

Coronavirus (COVID-19) Update: June 29, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The FDA has sent to Congress…

Coronavirus (COVID-19) Update: June 25, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: Today, the FDA is announcing revisions…

FDA In Brief: FDA Encourages Inclusion of Patients with Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies

The following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic…

Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and…

Coronavirus (COVID-19) Update: June 22, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: FDA issued a Drug Safety Communication…

FDA Approves First Oral Blood Thinning Medication for Children

Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with…

FDA Approves a Nasal Antihistamine for Nonprescription Use

The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The…