FDA Approval The latest news regarding FDA applications, processes and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions and safety alerts.

Latest FDA Approval

17 Apr, 2018, 20:19 BST Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita® (burosumab-twza) for the Treatment of Children and Adults with X-Linked Hypophosphatemia (XLH)

First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease...


16 Apr, 2018, 11:50 BST Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

-- FDA Action Expected by Jan. 31, 2019 -- -- Conference Call Scheduled for Today at 8:30 a.m. ET -- Alkermes plc (Nasdaq: ALKS) today...


21 Mar, 2018, 13:00 GMT Longhorn Vaccines and Diagnostics LLC receives de novo clearance by the U.S. Food and Drug Administration for PrimeStore® Molecular Transport Medium establishing a new class of microbial nucleic acid stabilization devices for molecular testing

PrimeStore® MTM was designed to rapidly inactivate pathogens within the sample and stabilize the RNA and DNA to provide safer and more efficient...


02 Mar, 2018, 13:30 GMT Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with standard...


26 Feb, 2018, 01:00 GMT Alma Lasers Inc., the North American Subsidiary of Sisram Medical, Receives New FDA Clearance on its Award Winning Soprano ICE Platform, the Gold Standard in Laser Hair Removal, Signaling a New Era in Aesthetic Technology Advancement

Alma Lasers, a subsidiary of Sisram Medical Ltd ("Sisram" or the "Company"; stock code: 1696.HK), the leading global innovator of laser...


08 Feb, 2018, 12:00 GMT Norgine's PLENVU® (NER1006) Receives Approval in Germany for Bowel Cleansing in Adults Prior to any Procedure Requiring a Clean Bowel

- PLENVU® is the first 1-litre PEG bowel preparation - PLENVU® is superior to MOVIPREP® in providing high-quality cleansing in...


01 Feb, 2018, 11:11 GMT Grünenthal Group Receives FDA's Expedited Access Pathway Designation for VIVO

Grünenthal announced today that Adhesys Medical Inc., a wholly-owned subsidiary of Grünenthal, has been granted Expedited Access Pathway (EAP)...


29 Jan, 2018, 07:18 GMT SyntheticMR AB - Segmentation and Quantification of Brain Tissue, and Industry First Myelin Volume Measurements in SyMRI now FDA Cleared

The new regulatory clearance from the American Food and Drug Administration, FDA, concerns the SyMRI NEURO product package. Combined with FDA's...