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

10 Dec, 2018, 12:00 GMT Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift™ Pixel CO2 System

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a...


10 Dec, 2018, 03:30 GMT Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift™ Pixel CO2 System

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a...


10 Dec, 2018, 01:00 GMT FDA Grants Orphan-drug Designation for TauRx's LMTX in Frontotemporal Dementia

TauRx, a leader in neurodegenerative disease research, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug...


04 Dec, 2018, 22:00 GMT Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift[TM] Pixel CO2 System

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a...


21 Nov, 2018, 10:00 GMT OBI Pharma Granted FDA Orphan Drug Designation for OBI-888 for the Treatment of Pancreatic Cancer

OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...


13 Nov, 2018, 02:00 GMT Esco Medical secures CFDA approval on the MIRI(R) TL and MIRI(R) Embryo Incubators

Esco Medical, the IVF medical technology business unit of the Esco Group, today announced that it has received the China Food and Drug Administration ...


07 Nov, 2018, 10:00 GMT HemoScreen™ Hematology Analyzer for Point of Care, Receives FDA 510(k) Clearance

PixCell Medical announced today that The HemoScreen™ Hematology Analyzer received FDA 510(k) clearance, enabling commercialization in the USA. The...


29 Oct, 2018, 12:00 GMT Jazz Pharmaceuticals Announces FDA Approval of Xyrem® (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug...


25 Oct, 2018, 18:00 BST Alcami Helps Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness

Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced ...


23 Oct, 2018, 14:22 BST COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression

COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received...


22 Oct, 2018, 11:15 BST FDA Grants Breakthrough Device Status for MediBeacon's Transdermal GFR Measurement System

MediBeacon Inc., whose largest shareholder is Pansend Life Sciences of HC2 Holdings, Inc. (NYSE MKT: HCHC), announced today the U.S. Food and Drug...


15 Oct, 2018, 16:00 BST CIVCO Radiotherapy Announces FDA 510k Clearance and CE Mark of their Solstice SRS Immobilization System

CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions, is delighted to announce FDA...


12 Oct, 2018, 15:05 BST FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing

Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative...


11 Oct, 2018, 16:22 BST Transseptal Solutions Announces FDA Clearance of Its Novel Transseptal Access System for Transseptal Puncture and Left Atrial Navigation

Transseptal Solutions Ltd., developer of an innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial...


03 Oct, 2018, 13:00 BST PARI Pharma's eFlow® Technology device, LAMIRA™, approved as the only nebulizer system to deliver Insmed's ARIKAYCE® (amikacin liposome inhalation suspension)

PARI Pharma GmbH, a company focused on the development and commercialization of advanced aerosol delivery systems based on eFlow Technology,...


19 Sep, 2018, 10:00 BST OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL)

OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...


19 Sep, 2018, 06:00 BST Pharming Receives Complete Response Letter from FDA

Additional clinical trial data for prophylaxis of HAE requested Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM)...


06 Sep, 2018, 07:57 BST NeuroVive Receives Positive FDA Feedback on its NeuroSTAT TBI Development Plan

NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced positive U.S. Food and Drug Administration (FDA) feedback on its...


22 Aug, 2018, 14:27 BST COMPASS Pathways Receives FDA Approval for Psilocybin Therapy Clinical Trial for Treatment-resistant Depression

COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received...


22 Aug, 2018, 13:00 BST MagVenture, Inc: FDA Clears 3-Minute, Non-Pharmaceutical Depression Treatment

For people suffering from severe depression, the road to remission just became a lot shorter: The treatment is known as Transcranial Magnetic...


14 Aug, 2018, 13:42 BST FDA Approvals for Cardiac Electrophysiology Products Bright Spot in Healthcare Industry

MarketNewsUpdates.com News Commentary The rising prevalence of cardiac conditions such as flutter, atrial fibrillation and arrhythmia has driven the...


08 Aug, 2018, 17:38 BST Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

Poteligeo has been approved for the treatment of the two most common types of Cutaneous T-cell lymphoma (CTCL) in previously treated patients based...


01 Aug, 2018, 13:00 BST FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...


30 Jul, 2018, 18:00 BST Sekisui Diagnostics Receives FDA Clearance for SEKURE® HbA1c Assay

Sekisui Diagnostics announces the FDA clearance of their SEKURE® HbA1c assay. The assay has been cleared to be used as an aid in the diagnosis of...


30 Jul, 2018, 18:00 BST Sekisui Diagnostics Receives FDA Clearance for SEKURE® HbA1c Assay

Sekisui Diagnostics announces the FDA clearance of their SEKURE® HbA1c assay. The assay has been cleared to be used as an aid in the diagnosis of...