The Latest Breaking News from FDA

US: FDA authorises COVID-19 vaccines for children under 5

President Joe Biden says jabs could be rolled out to that age group as early as next week, pending CDC recommendations.

Al Jazeera · Jun 17, 2022

Gov. Ron DeSantis reverses, allowing Florida health care providers to order vaccines for young children

WASHINGTON — Florida Gov. Ron DeSantis is now allowing health care providers, including pediatricians and children’s hospitals, to order COVID-19 vaccines from a federal program for children between 6 months and 5 years old, a reversal from earlier this week, White House officials told McClatchy.

McClatchy Washington Bureau · Jun 17, 2022

Government-Funded Smoking Cessation Trial Uses Mydecine's New Psilocybin-Derived MYCO-001, Recently FDA-Approved

Biotech company Mydecine Innovations Group (OTC: MYCOF) received FDA approval for their novel proprietary MYCO-001. This is the first clearance of the company’s drug product. 

Benzinga · Jun 17, 2022

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Nod For Kids As Young As Six Months

The FDA has granted emergency use authorization (EUA) to Pfizer Inc (NYSE:PFE) and BioNTech SE's (NASDAQ:BNTX) COVID-19 Vaccine as a three 3-µg dose series for children six months through 4 years of age.  Based on safety, tolerability, and immunogenicity data, the 3-µg dose was carefully selected as the preferred dose for children under five. The EUA…

Benzinga · Jun 17, 2022

The Daily Biotech Pulse: Addex Terminates Parkinson's Study, Expanded Use Of Rhythm's Obesity Drug, FDA Approval For AbbVie's Skyrizi In Crohn's Disease

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga · Jun 17, 2022

US authorizes first Covid vaccines for infants and preschoolers

FDA’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer

The Guardian - US · Jun 17, 2022

FDA clears Moderna, Pfizer COVID shots for children 5 and under

COVID vaccines for children ages 5 and under from Pfizer Inc. and Moderna Inc. received authorization from U.S. regulators, meaning almost all of the American population can soon get protected against COVID-19 disease.

Tribune News Service · Jun 17, 2022

Kazia Therapeutics' Shares Gain Following FDA Orphan Drug Status For Childhood Brain Cancer Drug

The United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Kazia Therapeutics’ (NASDAQ: KZIA) Paxalisib for the treatment of atypical rhabdoid / teratoid tumors (AT/RT), a rare and highly-aggressive childhood brain cancer.

Benzinga · Jun 17, 2022

FDA authorizes COVID vaccines for children as young as 6 months

The shots could start being administered as early as next week.

Axios · Jun 17, 2022

FDA authorizes 1st COVID-19 shots for infants, preschoolers

U.S. regulators have authorized the first COVID-19 shots for infants and preschoolers

The Independent UK · Jun 17, 2022