Category: FDA

LIVE: FDA Panel Considers COVID-19 Vaccines for Toddlers, Babies

On June 15, the Vaccines and Related Biological Products Advisory Committee will meet in an open session through an online teleconferencing platform to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to…


LIVE on June 15, 8:30 AM ET: FDA Panel Considers COVID-19 Vaccines for Toddlers, Babies

On June 15, the Vaccines and Related Biological Products Advisory Committee will meet in an open session through an online teleconferencing platform to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to…


FDA Approves First Drug of Its Kind to Restore Hair Growth in Severe Alopecia

The U.S. Food and Drug Administration has approved the first systemic treatment for alopecia areata—commonly referred to as just alopecia—a disorder that causes hair to fall out often in clumps on the scalp, face, and sometimes on other areas of the body. The drug, Olumiant (baricitinib), made by Eli Lilly, is now approved to treat adults…


FDA Decision on Novavax COVID-19 Shot May Be Delayed To Evaluate Changes in Manufacturing

The Food and Drug Administration’s (FDA) decision to authorize the Novavax COVID-19 vaccine for emergency use may be delayed due to the FDA reviewing changes to the company’s manufacturing process. Novavax told The Epoch Times that the company updated the FDA on changes to its manufacturing process on June 3, days before the advisory committee…


FDA Decision on Novavax COVID-19 Shot May Be Delayed

The Food and Drug Administration’s (FDA) decision to authorize the Novavax COVID-19 vaccine for emergency use may be delayed due to the FDA reviewing changes to the company’s manufacturing process. Novavax told The Epoch Times that the company updated the FDA on changes to its manufacturing process on June 3, days before the advisory committee…


Biden Administration Makes Available 10 Million Doses of COVID Vaccine for Kids Under 5 — Before FDA Authorizes Shot

The Biden administration today said it made available 10 million doses of COVID-19 vaccines for children under age 5 to states and healthcare workers with “millions more available in the coming weeks.” The White House unveiled its “Operational Plan” for vaccinating the youngest age group — one week before advisors to the U.S. Food and Drug Administration…


Doctors Sue FDA, Allege Crusade Against Ivermectin ‘Unlawfully Interfered’ With Their Ability to Treat Patients

In a lawsuit filed June 2, Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik argued the FDA acted outside of its authority by directing the public, including health professionals and patients, to not use ivermectin — even though the drug is fully approved by the FDA for human use. Three physicians are…


EXCLUSIVE: Congress Presses FDA on Why COVID-19 Vaccines Would be Authorized for Young Children

A group of members of Congress is pressing the U.S. Food and Drug Administration (FDA) for answers before the regulator decides whether to authorize COVID-19 vaccines for young children. All Americans aged 5 and older can get a COVID-19 vaccine. The FDA is scheduled to meet with its advisory panel on June 15 to discuss…


Company Recalls Organic Strawberry Tea Possibly Linked to Hepatitis A Outbreak

An organic tea is being recalled in several U.S. states over the possibility it contains organic strawberries potentially contaminated with Hepatitis A. The U.S. Food and Drug Administration (FDA) announced the voluntary recall of Organic Revitalizing Tea Tonic Strawberry Hibiscus Rose on Sunday. Urban Remedy contracts Youngstown Grape Distributors Inc. to co-manufacture the tea, which…


Doctors Suing Food and Drug Administration Over Ivermectin

A Washington law firm has filed a federal lawsuit against the U.S. Food and Drug Administration (FDA) for interfering with the use of ivermectin as a treatment for COVID-19. The lawsuit was filed by Boyden Gray & Associates on behalf of three doctors who were disciplined for prescribing human-grade ivermectin to patients. The firm’s founder,…