FDA Related News

Human Drugs

Clinical Trial Population Diversity Guidance

FDA issues a draft guidance to help clinical trial sponsors enhance the diversity of trial participants.

Medical Devices

UK Caution on Some Balloons, Stents

The UK Medicines and Healthcare Products Regulatory Agency cautions against using paclitaxel-coated balloons and drug-eluting stents in routine treatm...

Human Drugs

Celgene NDA for Ozanimod for Relapsing Multiple Sclerosis

FDA accepts a Celgene NDA for ozanimod, indicated for treating patients with relapsing forms of multiple sclerosis.

Biologics

R3 Stem Cell Responds to FDA Letter

R3 Stem Cell says it is unaware of any safety concerns resulting from stem cell contamination as raised in an FDA Notice of Violation.

Human Drugs

Palatin Gains Orphan Status for Uveitis Drug

FDA grants Palatin Technologies an orphan drug designation for PL-8177 for treating non-infectious intermediate, posterior, pan and chronic anterior u...

Human Drugs

Comments on FDA Insulin Biosimilar Docket

Six stakeholders comment on an FDA docket on the future of biosimilar insulins.

Medical Devices

DT MedTech PMA Approved for Ankle Replacement

FDA approves a DT MedTech PMA for the Hintermann Series H3 Total Ankle Replacement System.

Human Drugs

FDA Wants Another Trial for Motif Bios Iclaprim

Liver toxicity concerns prompt FDA to require an additional clinical trial before it can approve Motix Bios NDA for iclaprim, indicated for treating a...

Questions Raised About Biologics Interchangeability

Law professor Yaniv Heled raises concerns about the success potential of an FDA guidance on interchangeable biologics to lower drug costs.

Human Drugs

Mallinckrodt to Pay $15.4 Million on False Claims Charges

Mallinckrodt reaches an agreement in principle with the Justice Department to resolve False Claims Act allegations that it paid illegal kickbacks to d...