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.

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10 Jul, 2019, 14:00 BST INSIGHTEC Receives FDA Approval and CE Mark for Exablate Neuro With GE SIGNA Premier MR System

GE Healthcare, a leader in medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global medical technology innovator of...


09 Jul, 2019, 14:22 BST ConTIPI Medical Has Received FDA Approval for the Marketing of a Unique Product for the Treatment of Pelvic Organ Prolapse in Women

This week, ConTIPI Medical Ltd. received US Food and Drug Administration (FDA) approval to market its new product, the first of its kind, designed to ...


08 Jul, 2019, 20:15 BST icotec AG Granted FDA Clearance To Market VADER®one Pedicle Screw System

icotec AG, a Swiss company, today announced the VADER®one pedicle screw system was granted U.S. Food and Drug Administration (FDA) 510(k) clearance...


04 Jul, 2019, 12:08 BST BioInvent Receives Milestone Payment Related to TAK-169 Investigational New Drug Application

BioInvent International AB (BINV) today announced it will receive a $0.5 million milestone payment related to the acceptance by the U.S. Food and...


25 Jun, 2019, 13:00 BST Non-GMO BESTEVIA® Reb E receives FDA No Objection Letter

SweeGen, Inc., a stevia-based sweetener company, announced that the U.S. Food and Drug Administration (FDA) issued a GRAS (Generally Recognized As...


20 Jun, 2019, 12:17 BST Camurus Receives IND Acceptance From the FDA to Enter Phase 3 with CAM2029 for Treatment of Acromegaly

Camurus (NASDAQ STO: CAMX), a commercial stage biopharmaceutical company specializing in long-acting medicines for severe and chronic disorders,...


03 Jun, 2019, 08:00 BST Nouscom - IND for NOUS-209, an 'off-the-shelf' Neoantigen Cancer Vaccine, Cleared by FDA to Commence Clinical Development in MSI Solid Tumors

Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, announced today that its Investigational...


01 Jun, 2019, 04:25 BST Sihuan Pharm Post-launching Large-scale Clinical Trials of Cinepazide Maleate Injection were Completed With Efficacy Verified

Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) the largest cardio-cerebral vascular ("CCV") drug manufacturer in China's prescription drug...


27 May, 2019, 10:21 BST Sihuan Pharm Becomes the First Chinese Company that was Granted Approval for "Non-PVC Solid-Liquid Double Chamber Bag for Ceftazidime/Sodium Chloride Injection"

Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) ("Sihuan Pharmaceutical" or the "Group"), the largest cardio-cerebral vascular ("CCV") drug...


22 May, 2019, 13:00 BST EpiBone, Inc. Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF

EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) clearance to proceed...


16 May, 2019, 13:00 BST GenePOC Obtains FDA Clearance for Its GenePOC™ Carba Test in the US

GenePOC announces FDA clearance of its molecular diagnostic test for the detection and differentiation of the five most frequent gene sequences...


14 May, 2019, 13:07 BST FDA Approves TraceLink DSCSA Pilot Submission for Network Solutions; Delivering 2023 Traceability By Leveraging Blockchain and Digital Recalls Across a Supply Network

TraceLink Inc., the world's largest integrated digital supply network providing real-time information sharing for better patient outcomes, today...


10 May, 2019, 07:48 BST NeuroVive's IND for Clinical Development of NeuroSTAT Approved by FDA

NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced that the US Food and Drug Administration, FDA, has approved...


10 May, 2019, 03:05 BST Ally Bridge Group Leads Pulmonx's $65 Million Financing, Further Strengthening Its Global Medtech Franchise

Ally Bridge Group ("ABG"), a leading global life science investment group, announced today that it led an over-subscribed $65 million financing of...


07 May, 2019, 09:00 BST Rapid Medical Announces FDA Approval of Novel Temporary Aneurysm Embolization Assist Device

Rapid Medical, a company focused on the development of next generation neurovascular devices, today announced that its Comaneci device received FDA...


03 May, 2019, 19:00 BST ISAPS Applauds U.S. FDA Allowance of Textured-Surface Breast Implant Sales

The American Food and Drug Administration (FDA) issued a statement on Thursday in regards to the March 2019 public advisory hearing on breast...


02 May, 2019, 08:00 BST Concept Medical Inc. Granted 'Breakthrough Device Designation' From FDA for Its MagicTouch Sirolimus Coated Balloon

Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch, its...


23 Apr, 2019, 09:00 BST Rapid Medical Raises $20 Million in New Funding to Support Clinical and Commercialization of First-in-class Stroke Treatment Products

Rapid Medical, a company focused on the development of interventional neurovascular devices, announced today that it has completed an oversubscribed...


09 Apr, 2019, 14:00 BST Innoblative's SIRA™ RFA Electrosurgical Device Receives FDA Clearance

Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical...


08 Apr, 2019, 12:30 BST GT Biopharma Receives Institutional Review Board Approval to Proceed With in Human FDA Phase 1 Clinical Trial

T Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology biotechnology company focused on innovative treatments based on the Company's...


28 Mar, 2019, 13:30 GMT Mundipharma EDO GmbH: US FDA Grants Orphan Drug Designation for Tinostamustine in Very Rare Blood Cancer

Mundipharma EDO GmbH, and Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P., today announced that the US FDA has granted...


21 Mar, 2019, 13:00 GMT GenePOC Obtains FDA Clearance for Its GenePOC™ Strep A Test in the US

GenePOC Inc., member of the Debiopharm Group, announces its third test to be cleared by the FDA, the GenePOC Strep A assay, to be used with the...


20 Mar, 2019, 23:25 GMT Jazz Pharmaceuticals Announces U.S. FDA Approval of Sunosi™ (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Sunosi™ (solriamfetol) to improve...


19 Mar, 2019, 13:30 GMT Why the FDA Commissioner Pushed to Shorten Medical Device Approval Process

We all know the FDA is the arm of the U.S. government that, among other things, controls and oversees the approval process for medical device...


12 Mar, 2019, 20:20 GMT Hematogenix Launches FDA Approved Companion Diagnostic Immuno-oncology Test for Triple-Negative Breast Cancer

Hematogenix®- a global leader in the field of integrated pathology services for drug development and immuno-oncology testing, today announced the...