FDA Related News

Medical Devices

FDA Says ACIST Recall of Kodama Catheter is Class 1

FDA says the ACIST recall of 490 units of its Kodama intravascular ultrasound catheter is Class 1.

Human Drugs

Tremfya Arthritis Benefits Last Through 2 Years: Janssen

Janssen says treatment benefits from its Tremfya in psoriatic arthritis have been shown to last two years.

Human Drugs

Students Suggest Ways to Improve FDA Draft Antisense Oligonucleotide Guidance

Three students in a Duke University Science Regulation Lab course offer suggestions for FDA to improve a draft guidance on administrative and procedur...

Human Drugs

GSK Opens Phase 3 Asthma Study Using Anti-IL-5 Treatment

GlaxoSmithKline launches a Phase 3 trial of its GSK294 biologic to treat eosinophilic asthma.

Medical Devices

FDA Grants De Novo for Covid Diagnostic

FDA grants BioFire Diagnostics a De Novo marketing authorization for the BioFire Respiratory Panel 2.1, a diagnostic test for the simultaneous qualita...

FDA Touts Alternative Inspection Oversight Results

FDA acting commissioner Janet Woodcock and associate commissioner for regulatory affairs Judy McMeekin say the agency has succeeded in using alternate...

Human Drugs

Comments on FDA Dry Eye Drug Development Guidance

AbbVie and Allergan comment on a draft FDA guidance on developing drugs for dry eye.

Human Drugs

Lillys Mirikizumab Hits Ulcerative Colitis Trial Endpoints

Lilly says its mirikizumab hit primary and secondary endpoints in the LUCENT-1 ulcerative colitis Phase 3 induction study.

Federal Register

Comments Reopened on Orange Book Listings

Federal Register notice: FDA reopens the comment period for a 6/1/2020 notice entitled Listing of Patent Information in the Orange Book; Establishment...

Federal Register

FDA Withdraws Approval of 19 Not Marketed NDAs

Federal Register notice : FDA withdraws approval of 19 NDAs from multiple applicants after they notified the agency that the drugs were no longer mark...