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

24 May, 2018, 16:00 BST AGC Biologics Cleared for Commercial Manufacture of Portola's FDA-Approved Andexxa®

Drug Substance produced in AGC Biologics' facility in Bothell, Washington AGC Biologics, a global leader in clinical and commercial...


23 May, 2018, 12:42 BST BERG Announces FDA Orphan-Drug Designation of BPM 31510 for the Treatment of Patients with Epidermolysis Bullosa

BERG, LLC, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced that the...


22 May, 2018, 09:00 BST Bioprojet: Pitolisant Progresses Towards the U.S. Market

FAST TRACK AND BREAKTHROUGH DESIGNATIONS BY THE FDA AND FIRST U.S. NARCOLEPSY PATIENTS INCLUDED IN AN EXPANDED ACCESS PROGRAM Bioprojet is...


08 May, 2018, 14:02 BST First Cardiac Procedure Using the AcQMap® System by Acutus Medical® Successfully Performed in the United States

- New European/Canadian Clinical Study Initiated to Evaluate the AcQMap® System During an Atrial Fibrillation Retreatment Ablation Procedure -...


08 May, 2018, 08:00 BST FDA Grants Fast Track Designation to Debiopharm International's Debio 1347 for the Treatment of Patients With Unresectable or Metastatic Tumors With a Specific FGFR Gene Alteration

Debiopharm International SA (Debiopharm - www.debiopharm.com), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company,...


07 May, 2018, 12:00 BST Norgine Announces US FDA Approval for PLENVU® (NER1006) - 1 Litre PEG Based Bowel Cleansing Preparation for Colonoscopy

- US launch date: second half of 2018 - In Europe, PLENVU® is available through Norgine Norgine B.V. today announced that...


30 Apr, 2018, 14:00 BST Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Filing supported by data from MERIT-1 trial evaluating OPSUMIT in adults with inoperable CTEPH which showed significant improvements in pulmonary...


25 Apr, 2018, 10:00 BST FDA Accepts Clinical Research Plan to Explore Senzer's Inhaler for Cancer Patients

The US Food and Drug Administration have accepted an application for a clinical development study on Dronabinol Inhalation using Senzer's unique...


24 Apr, 2018, 08:00 BST Quotient Limited Announces FDA Approval of Seven Blood Bank Reagents, Including Two Market Firsts

Quotient Limited ("Quotient") (NASDAQ: QTNT), an established, commercial-stage diagnostics company, today announced the recent FDA approval for...


19 Apr, 2018, 10:00 BST OBI Pharma Announces FDA Clearance of OBI-3424 IND Application for A Phase I/II Study Targeting AKR1C3 Solid Tumors

First clinical trial to test the safety and efficacy of a novel first-in-class targeted therapy (small-molecule prodrug) that selectively releases...


18 Apr, 2018, 08:39 BST NeuroVive's KL1333 Receives FDA Orphan Drug Designation for Treatment of Mitochondrial Diseases

NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF), the mitochondrial medicine company, today announced that it has been granted...


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...