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Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children

Pfizer will acquire Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in migraine treatments, for $11.7 billion.

Pfizer to Acquire Biohaven Pharmaceuticals for $11.7 Billion

The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.

FDA Launches Accelerated Rare Disease Cures Program

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

FDA Limits Use of Janssen COVID-19 Vaccine

 Washington Editor, jillwechsler7@gmail.com.

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.

Escalating Abortion Battle Threatens FDA Authority

Purolite has received the Queen’s Award for Enterprise in the International Trade category.

Purolite Awarded Queen’s Award for Enterprise

Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives. 

Congress Presses FDA on Key Policies and Operations 

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.

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

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

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

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

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