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

Jun 27, 2017, 08:00 ET Philips receives FDA 510(k) clearance to market multiple new applications on its IntelliSpace Portal platform for Radiology

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and...


Jun 27, 2017, 07:00 ET OWC Pharmaceutical Research Corp. Announces Market Readiness of its Cannabinoid-based Topical Cream for Skin Conditions Starting With Psoriasis

OWC Pharmaceutical Research Corp. (OTCQB: OWCP) today announced that its wholly-owned, Israel-based subsidiary, One World Cannabis Ltd. (OWC),...


Jun 27, 2017, 03:05 ET Equashield Ltd, ontwikkelaar van gesloten systemen voor toxische geneesmiddelen bereidingen tekent exclusiviteitsovereenkomst met Aagato Medical BVBA voor de top CSTD landen België en Luxemburg

Equashield (http://www.equashield.com ), een vooraanstaand leverancier van Gesloten Systemen voor Veilige Bereiding en Toediening (CSTDs) van...


Jun 27, 2017, 03:05 ET Le fournisseur de dispositifs de transfert en système clos Equashield signe un accord de distribution exclusif avec Aagato Medical BVBA sur le marché des systèmes CSTD de pointe en Belgique et au Luxembourg

Equashield (http://www.equashield.com), un fournisseur incontournable de dispositifs de transfert en système clos (CSTD) pour la manipulation de...


Jun 26, 2017, 14:37 ET Kitov Updates on KIT-302 New Drug Application

Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that it has begun the...


Jun 26, 2017, 12:01 ET Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Azacitidine for Injection (Vidaza®)

Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA Azacitidine for Injection, 100mg per vial, Single-Dose...


Jun 26, 2017, 10:32 ET Ortho Clinical Diagnostics Receives FDA 510(k) Clearance for Ortho's VITROS® Insulin Reagent & Calibrators

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that Ortho's VITROS® Immunodiagnostic Products Insulin Reagent...


Jun 26, 2017, 09:00 ET Validated, Organic, Non-Thermal Food Safety Solution Neo-Pure Marks First Year With Expanded Food Segments, Growing Customer Base And FDA Approval

Last year at IFT's Annual Meeting & Food Expo, food safety company Agri-Neo introduced Neo-Pure, its validated food safety...


Jun 26, 2017, 06:51 ET Lannett Receives Approval For Additional Dosage Strengths Of Hydrocodone Bitartrate And Acetaminophen Tablets USP

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


Jun 23, 2017, 14:16 ET FDA Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), First and Only Subcutaneous Preventive Treatment for Hereditary Angioedema

Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved...


Jun 23, 2017, 09:20 ET Roche receives FDA approval for fourth-generation HIV combination antigen-antibody assay --allowing detection of infection with high sensitivity and specificity

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT...


Jun 22, 2017, 17:47 ET Novartis combination targeted therapy Tafinlar® + Mekinist® receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC)

Novartis today announced the US Food and Drug Administration (FDA) approval of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) to...


Jun 22, 2017, 17:03 ET FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease

The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin)...


Jun 22, 2017, 17:02 ET FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies

The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing...


Jun 22, 2017, 15:16 ET FDA Approves Genentech's RITUXAN HYCELA, A Subcutaneous Rituximab Coformulated With Halozyme ENHANZE Technology

Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced...


Jun 22, 2017, 13:54 ET FDA Clears Insulin Algorithms Comprehensive Insulin-Titration Software For Clinicians

The U.S. Food & Drug Administration has cleared as a Class II medical device Insulin Algorithms' decision-support software, which helps...


Jun 22, 2017, 06:53 ET Lannett Receives Approval For Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg And 10 mg/300 mg

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


Jun 21, 2017, 11:22 ET Beckman Coulter Diagnostics Expands Chemistry Menu to include FDA-cleared Procalcitonin (PCT)

Beckman Coulter Diagnostics along with partner Diazyme Laboratories announces FDA clearance of a new procalcitonin (PCT) assay, an important tool...


Jun 21, 2017, 10:34 ET Additive Orthopaedics Announces FDA Clearance of their Minimally-Invasive, Intramedullary 3D Printed Bunion Correction System for the Extremities Market

Additive Orthopaedics, LLC., an orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed...


Jun 21, 2017, 09:00 ET Kadimastem Received Approval from the Hadassah Hospital IRB (Helsinki Committee) for Conducting a Clinical Trial in ALS Patients

Israeli biotechnology company Kadimastem (TASE: KDST) announced today that it had received approval from the IRB (Helsinki Committee) of the...


Jun 20, 2017, 18:48 ET Shire plc: U.S. FDA Approves Mydayis[TM] (Mixed Salts of a Single-Entity Amphetamine Product) - A New Once-Daily Option for ADHD Symptom Control in Patients 13 Years and Older

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved MYDAYIS[TM] (mixed salts of a...


Jun 20, 2017, 09:06 ET Egalet Receives Complete Response Letter from U.S. Food and Drug Administration for Prior Approval Supplement for 10 mg and 15 mg Dosage Strengths of OXAYDO

Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing...


Jun 20, 2017, 08:30 ET Intezyne Technologies Granted Orphan Drug Designation for IT-139 in Pancreatic Cancer

Intezyne Technologies, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that that the Office of Orphan...


Jun 20, 2017, 06:59 ET BD Receives FDA 510(k) Clearance for New Line of Customizable, 3.0mm Micro-Laparoscopic Instruments

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that its new line of Snowden-Pencer™...


Jun 19, 2017, 09:00 ET FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA® (denosumab) To Include Multiple Myeloma Patients

Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denosumab) supplemental...