FDA Related News

Biologics

Regenerelle Marketing Unapproved HCT/P Products: FDA

An FDA Notice of Violation says Fairport, NY-based Regenerelle is marketing stem cell and exosome products without required drug and biologic approval...

Medical Devices

Integra Recalls Products Over Endotoxin Testing

Integra LifeSciences recalls all products manufactured at its Boston, MA facility due to inadequate endotoxin testing.

PhRMA, BIO Commend FDA Digital Health Efforts

PhRMA and BIO praise FDA efforts to use digital health technology in drug and biologic regulatory decisions.

Federal Register

Panel to Discuss Ipsens Palovarotene NDA

Federal Register notice: FDA announces a 6/28 advisory committee meeting to discuss an Ipsen Biopharmaceuticals NDA for palovarotene capsules.

Human Drugs

Phathom Resubmits Vonoprazan NDA

Phathom Pharmaceuticals resubmits its NDA for vonoprazan tablets to treat erosive gastroesophageal reflux disease, responding to a complete response l...

Biologics

Celltrion Biosimilar Copy of Humira Approved

FDA approves a Celltrion BLA for Yuflyma (adalimumab-aaty), biosimilar copy of AbbVies blockbuster Humira.

Federal Register

Info Collection on FDA Service Delivery Feedback

Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for the Collection of Qualitative Feedba...

Human Drugs

Generally Accepted Scientific Knowledge Guidance

FDA publishes a draft guidance on using generally accepted scientific knowledge in drug and biological product applications.

Biologics

FDA Extends Review of Sarepta Gene Therapy

FDA extends by three weeks its review of a Sarepta Therapeutics BLA for SRP-9001 (delandistrogene moxeparvovec), a gene therapy product for treating a...

Medical Devices

Tox Study Whole Slide Imaging Guidance

FDA publishes a Q&A guidance on using and managing whole slide images used during histopathology assessment and/or pathology peer review.