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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May 21, 2018, 08:30 ET Nestlé Skin Health Announces the FDA Approval of Restylane® Lyft for Hands, the First and Only Hyaluronic Acid (HA) Dermal Filler for Use in the Back of Hands

Nestlé Skin Health, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug...


May 21, 2018, 08:00 ET Zavante Therapeutics To Present Fosfomycin For Injection Data At ASM Microbe 2018 Meeting

Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients,...


May 21, 2018, 06:53 ET Lannett Receives FDA Approval For Dronabinol Capsules

Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New...


May 17, 2018, 19:15 ET FDA approves novel preventive treatment for migraine

The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is...


May 17, 2018, 19:11 ET Novartis and Amgen announce FDA approval of Aimovig™ (erenumab-aooe), a novel treatment developed specifically for migraine prevention

Novartis today announced that the US Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-aooe) for the preventive treatment of...


May 17, 2018, 19:04 ET FDA Approves Aimovig™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention

Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-aooe) for the preventive...


May 17, 2018, 09:15 ET Amneal Announces FDA Approval and Launch of Generic Welchol® (Colesevelam HCl) Tablets, 625 mg

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug...


May 16, 2018, 17:55 ET FDA Approves US WorldMeds' LUCEMYRA™ (lofexidine) After Priority Review for the Management of Opioid Withdrawal Symptoms

US WorldMeds today announced that the US Food and Drug Administration (FDA) approved LUCEMYRA (lofexidine) for mitigation of opioid withdrawal...


May 16, 2018, 16:22 ET FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate...


May 16, 2018, 15:28 ET Additive Orthopaedics Announces FDA Clearance of their Patient Specific 3D Printed Bone Segments for the Global Extremities Market

Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, today announced that is has received FDA 510(k) clearance...


May 16, 2018, 08:30 ET Castle Creek Pharmaceuticals Receives FDA Rare Pediatric Disease Designation for Diacerein 1% Ointment for Epidermolysis Bullosa

Castle Creek Pharmaceuticals (CCP), a global company dedicated to delivering transformative therapies to patients with orphan dermatologic and...


May 15, 2018, 11:56 ET FDA approves first epoetin alfa biosimilar for the treatment of anemia

The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the...


May 15, 2018, 10:53 ET Xcaliber International Receives SE Orders from The FDA

On May 10, 2018, Xcaliber International, Ltd., L.L.C. ("Xcaliber"), a Pryor, Oklahoma based cigarette manufacturer, received 15 orders from the...


May 15, 2018, 09:00 ET Medic Vision: New FDA-cleared MRI Image Enhancement Technology Enables Reduction of Scan Time and Increased Resolution

Medic Vision Imaging Solutions, Ltd., the leading innovator of vendor-independent solutions for CT and MRI scanners, today announced that the U.S....


May 15, 2018, 09:00 ET Caliber Imaging & Diagnostics, Inc. Announces FDA 510(k) Clearance for its VIVASCOPE System

Caliber Imaging & Diagnostics Inc. (Caliber I.D.) announced today that it has received 510(k) clearance from the Food and Drug Administration...


May 15, 2018, 07:00 ET FDA Clears Expanded Claims for 'Superbug' Test

Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, an...


May 14, 2018, 09:00 ET Allium Medical Receives CFDA Clearance to Market its Minimally-invasive BPH Implant and Premium Urological Stents in China

Allium Medical (TASE: ALMD) - an Israeli medical device company that specializes in minimally invasive technologies and solutions, announced...


May 14, 2018, 08:00 ET Grifols Expands its Blood Typing Solutions Portfolio in the United States with Antisera Reagents

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


May 14, 2018, 07:00 ET CurveBeam Announces FDA 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System

CurveBeam announced it has received FDA 510(k) clearance for its LineUP Multi-extremity weight bearing CT system. The compact system enables...


May 14, 2018, 01:00 ET FDA approves additional claim for Roche cobas Zika test

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today FDA approval of an additional claim for the cobas® Zika test for use on the cobas® 6800/8800...


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