Biologics
Cell and Gene Therapy Product Manufacturing Considerations
FDA issues a guidance to give manufacturers of licensed and investigational cellular and gene therapy products risk-based recommendations to minimize ...
Human Drugs
sNDA for Esbriet in Lung Disease Gets Priority Review
FDA accepts for priority review a Genentech supplemental NDA for Esbriet (pirfenidone) for treating unclassifiable interstitial lung disease.
Federal Register
New Tobacco Products Applications Guide Withdrawn
Federal Register notice: FDA withdraws a draft guidance entitled Applications for Premarket Review of New Tobacco Products.
Medical Devices
Canon Aquilion Exceed CT System Cleared
FDA clears a Canon Medical Systems 510(k) for the Aquilion Exceed LB CT system.
Human Drugs
PhRMA Wants More Complete Interchangeability Guidance
PhRMA asks for changes to an FDA draft guidance on biosimilarity and interchangeability.
Human Drugs
FDA Approves Cabenuva for HIV-1 Infection
FDA approves ViiVs Cabenuva and Vocabria to treat HIV-1 infection in some adults.
Human Drugs
FDA Accepts 2 Opdivo sBLAs for New Indications
FDA accepts two sBLAs for new indications for Bristol-Myers Squibbs Opdivo and sets PDUFA goal dates in May.
Medical Devices
FDA Clears 2 Siemens Digital Radiography Devices
FDA clears a Siemens Healthineers 510(k) for the Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Multix Impact VA20, a ...
Human Drugs
Impel NeuroPharma NDA for Migraine Drug
FDA accepts for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migraine headaches with o...
Federal Register
Rule on Premarket Tobacco Product Application Requirements
Federal Register notice: FDA issues a final rule that outlines requirements for premarket tobacco product applications and requires manufacturers to m...
