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FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs NMPA
September 23, 2021
The following quote is attributed to Theresa M. Michele, M.D., director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research
FDA Approves Korsuva (difelikefalin) Injection for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients drugs
August 26, 2021
Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved Korsuva (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease.
FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Pediatric Growth Hormone Deficiency drugs
August 26, 2021
Ascendis Pharma A/S today announced that the U.S. Food and Drug Administration (FDA) has approved Skytrofa (lonapegsomatropin-tcgd) for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) .
US clears Ascendis' once-weekly paediatric growth hormone injection firstwordpharma
August 26, 2021
Ascendis Pharma said Wednesday that the FDA has approved Skytrofa (lonapegsomatropin-tcgd) as a once-weekly treatment for paediatric patients aged one year and older who have growth failure due to inadequate secretion of endogenous growth hormone.
Servier Announces FDA Approval of TIBSOVO (ivosidenib tablets) in IDH1-Mutated Cholangiocarcinoma firstwordpharma
August 26, 2021
Servier Pharmaceuticals announced today that the U.S. Food and Drug Administration approved TIBSOVO®(ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation.
FDA Warns Against 'Off-Label' Use of Pfizer COVID-19 Vaccine in Younger Children drugs
August 25, 2021
"Off-label" use of the Pfizer COVID-19 vaccine in children younger than 12 years is "not appropriate," the U.S. Food and Drug Administration warned Monday. The American Academy of Pediatrics (AAP) also "strongly discourages" such use.
FSD Pharma Announces Termination of FSD-201 Phase 2 Clinical Trial firstwordpharma
August 25, 2021
FSD Pharma Inc. (Nasdaq:HUGE) (CSE:HUGE) (FRA:0K9) (the "Company" or "FSD") announced today that it intends to terminate the Phase 2 clinical trial of ultra-micronized palmitoylethanolamide ("PEA"), or FSD-201, for use in treating COVID-19.
Advancing Generic Drug Development: Translating Science to Approval fda.gov
August 25, 2021
The purpose of the public workshop is to communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval.
FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older drugs
August 24, 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for Comirnaty (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years.
Stop Using Ivermectin Veterinary Drug to Treat COVID-19, FDA Urges drugs
August 24, 2021
Taking a drug meant for horses and cattle to prevent or treat COVID-19 is dangerous and could be fatal, the U.S. Food and Drug Administration warns.

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