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

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...


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...


19 Jan, 2018, 11:03 GMT Grünenthal Group Receives CE-Certification for Innovative Surgical Sealant

Grünenthal announced today that Adhesys Medical GmbH, a wholly-owned subsidiary of the Grünenthal Group, has received CE-Certification for...


15 Jan, 2018, 07:00 GMT Norgine's PLENVU® (NER1006) Receives Austrian, Australian, French, Irish, Italian and Portuguese Approvals 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...


11 Jan, 2018, 12:00 GMT Norgine Launches Lymphoseek®▼ in Finland and Sweden

Norgine B.V. today announced the launch of LYMPHOSEEK® (Tc 99m tilmanocept) in Finland and Sweden. LYMPHOSEEK® is a radiopharmaceutical used for...


10 Jan, 2018, 09:07 GMT BioProtect Launches an International Multi-Center Clinical Study Following FDA investigational Device Exemption (IDE)

FDA has granted investigational Device Exemption approval (IDE) to conduct a pivotal clinical study examining the use of the ProSpace[TM]...


04 Jan, 2018, 16:10 GMT Sight Sciences Expands Surgical Portfolio with FDA Clearance of the OMNI™ Surgical System

Simultaneously Announces Three Key Hires to Establish Commercial Leadership Team Sight Sciences, Inc., a venture-backed, commercial stage...


23 Dec, 2017, 09:00 GMT Bringing Access to Biologics

Abdi Ibrahim Remede Pharma (AIRP) is Biocon's partner in Algeria for the registration, marketing and pharmacovigilance monitoring of...


07 Dec, 2017, 01:00 GMT Magnair™ an eFlow® Closed System Nebulizer together with Sunovion's Lonhala™ is the first eFlow technology based product to receive FDA Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

- LONHALA MAGNAIR Inhalation Solution is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the...


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