USA – FDA officials tout steady growth in biosimilar program, enhancements under FDORA
US Food and Drug Administration (FDA) officials touted “steady growth” in the total number of biosimilar products since the program’s inception, with 40 approvals...
USA – Pharmacogenomic data guidance: Industry objects to reporting exploratory studies
An industry group representing pharmaceutical and biotechnology companies is asking the US Food and Drug Administration (FDA) not to require the reporting of results...
USA – FDA finalizes guidance on charging for investigational drugs
The US Food and Drug Administration (FDA) on 14 February finalized guidance specifying the circumstances when sponsors can charge for an investigational drug in...
USA – FDA issues draft guidance on developing migraine prevention drugs
The US Food and Drug Administration (FDA) on Thursday released a draft guidance to help sponsors develop drugs to prevent migraines that offers recommendations...
USA – FDA approves first treatment for Rett Syndrome
FDA has approved Daybue (trofinetide) oral solution as the first treatment for Rett syndrome, a rare, genetic neurological disorder. Daybue is approved for the...
USA – FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne...
Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of...
USA – FDA issues final guidance on obtaining informed consent in drug and device...
The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors...
USA – FDA finalizes multiple endpoints guidance
The US Food and Drug Administration’s (FDA) on Thursday finalized guidance to sponsors on managing multiple endpoints in clinical trials to minimize the likelihood...
USA – FDA proposes long-awaited patient medication information rule
The US Food and Drug Administration (FDA) has proposed new drug labeling requirements to make it easier for patients to understand their medication while...
USA – FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve...
