Archive for May, 2021

Coronavirus (COVID-19) Update: May 28, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: This week, FDA released…

FDA Seeks $6.5 Billion to Further Investments in Critical Public Health Infrastructure, Core Food Safety and Medical Product Safety Programs

The U.S. Food and Drug Administration is requesting a total budget of $6.5 billion as part of the President’s fiscal year (FY) 2022 budget –…

FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy

Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have…

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate…

FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility

Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim…

FDA In Brief: FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance

The following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center…

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

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, the FDA updated…

FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom

UPDATE: On October 26, 2021, Judge Sheri Polster Chappell of the United States District Court for the Middle District of Florida entered a consent decree…

Coronavirus (COVID-19) Update: May 21, 2021

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

FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have…