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

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...


05 Dec, 2017, 13:15 GMT Merck Announces FDA 510(k) Clearance of Partner Genea Biomedx's Fertility Benchtop Incubator Geri™

Not intended for U.S. based media - Expanded Fertility Technology portfolio highlights Merck's commitment to improve fertility...


01 Dec, 2017, 01:59 GMT FDA Approves SUBLOCADE™ (Buprenorphine Extended-Release), the First and Only Once-Monthly Injectable Buprenorphine Formulation to Treat Moderate to Severe Opioid Use Disorder

SUBLOCADE Expected to be Available to U.S. Patients in Q1 2018 This announcement contains inside information. Indivior PLC (LON: INDV)...


29 Nov, 2017, 09:00 GMT Insightec: The Taiwanese Food and Drug Administration (TFDA) Approved Exablate Neuro for the Treatment of Essential Tremor

INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, announced today that the Taiwanese Food and Drug Administration (TFDA) has...


27 Nov, 2017, 09:00 GMT FDA Clearance For Perspectum Diagnostics' LiverMultiScan™ Means More Patients Can Benefit From Access To State-Of-The-Art Non-Invasive Diagnostic Aid For Liver Disorders

- More patients can benefit from non-invasive assessment of the liver through expanded compatibility with MRI systems - LiverMultiScan™...


22 Nov, 2017, 21:00 GMT FDA Approves RxSight's Light Adjustable Lens, First IOL To Enable Refractive Correction After Cataract Surgery

Company also announces CE Mark certification RxSight, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the...


22 Nov, 2017, 00:35 GMT Juluca® (Dolutegravir and Rilpivirine) Approved in US as First 2-drug Regimen, Once-daily, Single Pill - a Complete Regimen for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection

ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders,...


16 Nov, 2017, 13:00 GMT Insulia receives FDA clearance and CE mark to integrate Basaglar and Tresiba

Insulia now cleared for titration of all brands of basal insulin Today, Voluntis announced that Insulia®, its digital companion for people...


14 Nov, 2017, 18:00 GMT Roche receives FDA clearance for the VENTANA MMR IHC Panel for patients diagnosed with colorectal cancer

-- The VENTANA MMR IHC Panel1 helps differentiate between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal...


13 Nov, 2017, 13:15 GMT Merck Receives FDA Approval for New GONAL-f® Prefilled Pen

- New pen is easy-to-learn and easy-to-use, supporting the one in six couples affected by infertility in the U.S.[1] - Insights of...


07 Nov, 2017, 15:58 GMT Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for treatment with Roche's ALECENSA (alectinib)

- The VENTANA ALK (D5F3) CDx Assay(1) companion diagnostic is now indicated as an aid in identifying lung cancer patients eligible for treatment...


01 Nov, 2017, 12:30 GMT FDA's Efforts to Accelerate New Drug Development is a Big Bonus for Biotech and Pharma Stocks

The U.S Food and Drug Administration is taking advantage of latest policy guidance spelled out in past years to speed drug approvals. Thirty-four...


31 Oct, 2017, 15:03 GMT EYE TECH CARE Receives CFDA Approval for its EyeOP1(R) Glaucoma Treatment product

Award-winning medical technology company EYE TECH CARE has received approval from the China Food and Drug Administration (CFDA) to begin marketing...


31 Oct, 2017, 12:45 GMT Key FDA Approvals Paramount Catalyst for Biotech Run Heading Into November

The FDA has approved 34 drugs to date in 2017 after approving 22 novel drugs last year. Many biotech and pharma companies have dealt with the drug...


27 Oct, 2017, 04:30 BST United States Food and Drug Administration (USFDA) - BioResearch Monitoring Program (BIMO) Conducted 2 Inspections at Veeda CR - Ahmedabad

Veeda Clinical Research is glad to share the successful completion of 2 USFDA Inspections at 2 of its locations at Ahmedabad in Sep-2017. Both...


26 Oct, 2017, 21:59 BST Endo Files Federal Lawsuit to Obtain FDA Compliance with Drug Quality and Security Act of 2013

Endo International plc (NASDAQ: ENDP) today announced that its subsidiaries, Par Sterile Products, LLC and Endo Par Innovation Company, LLC, filed...