FDA Related News

Biologics

Better Vaccine Communication Needed: Column

A MedPageToday column calls for a whole new approach to communicating about vaccines to persuade people to use them.

Human Drugs

FDA Modernization Act 3.0 Reintroduced

Sen. Cory Booker and eight others in a bipartisan coalition reintroduce legislation to force FDA to implement the FDA Modernization Act that Congress ...

FDA General

RFK Jr. Grilled by Dems at Confirmation Hearing

Robert F. Kennedy Jr. faces heated questioning during his confirmation hearing for his stances on vaccines, abortion rights, and conflicts of interest...

Biologics

FDA Accepts BLA for Alvotechs Simponi BLA

FDA accepts for review an Alvotech and Teva Pharmaceuticals BLA for AVT05, a proposed biosimilar to Janssen Biotechs Simponi and Simponi Aria (golimum...

Human Drugs

Enhertu Approval Broadens Breast Cancer Use

FDA approves AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic hormone rece...

Human Drugs

No Informed Consent at Trial Site: FDA

FDA warns the Miami Dade Medical Research Institute and Dr. Americo Padilla about failing to obtain proper informed consent for pediatric patients in ...

Biologics

2 Firms Illegally Selling Biologics: FDA

FDA warns New York, NY-based Evolutionary Biologics and Chatsworth, CA-based Chara Biologics about illegally manufacturing and distributing unapproved...

Human Drugs

FDA Priority Review for New Merck Welireg Indication

FDA sets 5/25 for its decision on a new indication for Mercks Welireg to treat patients with advanced pheochromocytoma and paraganglioma.

Medical Devices

AI Optics Handheld Retinal Imager Cleared

FDA clears an AI Optics 510(k) for its Sentinel Camera, a handheld retinal imaging device for capturing images of the human eye.

TerSera Wants Prialt ANDA Conditions

TerSera petitions FDA to require any ANDA referencing Prialt to conduct compatibility testing with the Medtronic pump that is specified in Prialts lab...