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

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...


24 Oct, 2017, 13:03 BST Acutus Medical® Receives FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias

FDA clearance of the AcQMap® High Resolution Imaging and Mapping System and AcQMap® 3D Imaging and Mapping Catheter is a major milestone for Acutus...


19 Oct, 2017, 12:19 BST SafeTraces Secures $6.5 Million Series A Financing Round Led by Omidyar Network to Advance Disruptive On-Food Source Assurance Solutions

SafeTraces also received a prestigious FDA SBIR Phase II grant to advance commercialization of its rapid safety solution for fresh produce...


19 Oct, 2017, 07:00 BST Merck Brings Customers Closer to Gene Therapy Product Commercialization

- Company's Carlsbad, U.S., manufacturing facility passes FDA and EMA inspections - Underscores capabilities as commercial manufacturer of viral...


18 Oct, 2017, 13:45 BST Positive Developments From Clinical Studies and FDA Approvals Pushing Biotech Stocks to New Highs

Biotech Briefing: The Biotech Sector continues to impress and even surprise many as the SPDR S&P Biotech ETF (XBI) has surged 49 percent in...


10 Oct, 2017, 15:24 BST Respicardia's remedē® System Receives FDA Approval

Breakthrough Treatment of Moderate to Severe Central Sleep Apnea in Adult Patients Now Available Respicardia, Inc., a private medical...


10 Oct, 2017, 13:30 BST Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab's Biologics License Application

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare...


06 Oct, 2017, 13:07 BST Game Ready® Receives FDA 510(k) Clearance For Med4 Elite™ Multi-Modality Recovery Device

The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food...


04 Oct, 2017, 18:00 BST Transfer of Regulatory Jurisdiction for Oxitec's Self-limiting Friendly™ Aedes in the United States

FDA issues final Guidance for Industry, transferring regulatory authority to EPA Following new Guidance issued by the U.S. Food and Drug...


04 Oct, 2017, 09:00 BST CALCIVIS Closes Equity Funding to Advance its CALCIVIS Imaging System to Market

CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has...


27 Sep, 2017, 23:41 BST No More Routine Finger Sticks(1) for Americans with Diabetes: Abbott′s FreeStyle® Libre Approved in the U.S.

- REVOLUTIONARY SYSTEM TO REPLACE BLOOD GLUCOSE MONITORING, ELIMINATING THE NEED FOR ROUTINE FINGER STICKS(1) AND FINGER STICK CALIBRATION -...


18 Sep, 2017, 09:17 BST Camurus Announces That FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder

The FDA has assigned a PDUFA target date of January 19, 2018 Camurus (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration...


11 Sep, 2017, 06:00 BST Pharming Announces Conclusion of FDA End of Phase 2 Interactions on RUCONEST® for Prophylaxis of HAE

Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announced today that it has concluded its End-of-Phase 2...


31 Aug, 2017, 15:39 BST U.S. FDA Approves Chemo Group's Benznidazole to Treat Children with Chagas Disease

On August 29th, the U.S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole. This is the...


25 Aug, 2017, 07:30 BST US Food and Drug Administration Grants Breakthrough Therapy Designation for Mogamulizumab for the Treatment of Mycosis Fungoides and Sézary Syndrome

Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced that U.S. Food and Drug...