FDA News and Approvals: Publications and Resources

Summary: The FDA Drug and Product Approvals publications on Disabled World offer a range of articles and research relevant to medical advancements and safety. These publications include FDA announcements, research papers, and product releases covering topics such as new drug approvals like those for multiple sclerosis or Duchenne muscular dystrophy, medical device clearances such as glucose monitoring systems, and warnings regarding consumer products, like hand sanitizers or weight loss supplements. Many of the articles are peer-reviewed and offer updates, revisions, and insights that can be interesting, helpful, and of use to the general public, including seniors, people with disabilities, and those interested in staying informed about healthcare options and regulatory actions.

Searching the Academic Database: The data table below lists articles and research papers from our FDA News and Approvals category. Some items may be updated or revised, but the table defaults to sorting by descending publication date; you can search and sort by clicking column headers (JavaScript required).

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FDA News and Approvals: Publications and Resources
Title of Document	Paper Author	Peer Review	Preface / Postface	Publication Type	Publish Date	Updated / Revised
Cognoa ASD Diagnosis Aid Approved for Marketing by FDA	U.S. Food and Drug Administration	Yes		Product Release, Update	2021/06/03	2024/05/16
Neurolutions IpsiHand Upper Extremity Rehabilitation System	U.S. Food and Drug Administration			Announcement	2021/04/24	2024/08/23
Safety and Effectiveness of Consumer Hand Sanitizers	U.S. Food and Drug Administration				2019/04/11	2020/03/21
Generic Version of EpiPen Approved by U.S. FDA	U.S. Food and Drug Administration				2018/08/19
Scammers Target Consumers with Fake FDA Warning Letters	U.S. Food and Drug Administration				2018/07/13	2019/04/30
FDA Approves Glucose Monitoring System with Sensor and App for Adults with Diabetes	U.S. Food and Drug Administration (FDA)				2018/06/21	2019/02/08
Automated Insulin Delivery and Monitoring System for Younger Pediatric Patients Approved by FDA	U.S. Food and Drug Administration (FDA)				2018/06/21	2019/02/08
US FDA Authorizes First Fully Interoperable Continuous Glucose Monitoring System	U.S. Food and Drug Administration				2018/03/29
Statement From FDA Commissioner on Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices	U.S. FDA				2018/01/03	2018/03/15
FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers	U.S. Food and Drug Administration				2017/12/28	2018/03/15
FDA Approves Kymriah for Cancer and Life-threatening Diseases Treatment	U.S. Food and Drug Administration	Yes	✓ Preface ✓ Postface	Announcement	2017/09/22	2025/05/14
U.S. FDA Approves Radicava (Edaravone) to Treat ALS	U.S. Food and Drug Administration				2017/05/06
U.S. FDA Approves Ocrevus (Ocrelizumab) to Treat Multiple Sclerosis	U.S. Food and Drug Administration (FDA)				2017/03/30
Researchers Want More Transparency From the US FDA	Johns Hopkins University Bloomberg School of Public Health	Yes		Reports and Proceedings	2017/03/18	2023/09/19
FDA Approves Noctiva for Frequent Night Urination Treatment	U.S. Food and Drug Administration				2017/03/07
FDA Approves Emflaza (Deflazacort) to Treat Duchenne Muscular Dystrophy	U.S. Food and Drug Administration (FDA)				2017/02/09
Lawsuit Urges FDA to Protect Hair Salon Workers and Consumers from Formaldehyde	Environmental Working Group				2016/12/14
FDA Approves First Drug to Treat Duchenne Muscular Dystrophy	U.S. FDA				2016/09/20
FDA Challenged to Support Claims Regarding Electronic Cigarettes	E-Cigarette Reviewed				2013/02/20
Ethical Dilemmas Contribute to Weakness in FDA Postmarket Oversight	Johns Hopkins Medicine				2012/08/23	2021/08/05
Insomnia Drug Intermezzo Approved by FDA	U.S. Food and Drug Administration				2011/11/25
Cialis to Treat Benign Prostatic Hyperplasia Approved by FDA	U.S. Food and Drug Administration	Yes		Announcement	2011/10/13	2024/08/01
Boostrix for Tetanus, Diphtheria and Pertussis in Seniors	U.S. Food and Drug Administration				2011/07/10
FDA Approves Lazanda (Fentanyl) Nasal Spray for Breakthrough Cancer Pain	Archimedes Pharma Ltd.				2011/06/30
Global Strategy to Help Ensure Safety and Quality of Imported Products	U.S. Food and Drug Administration				2011/06/20
Injectable Gel to Treat Fecal Incontinence Approved by FDA	U.S. Food and Drug Administration				2011/05/28
Toxoplasmosis Parasite Infection Test	U.S. Food and Drug Administration				2011/05/24	2019/01/16
Sutent for Rare Type of Pancreatic Cancer Approved by FDA	U.S. Food and Drug Administration				2011/05/22
Q Fever Test for Military Serving Overseas	U.S. Food and Drug Administration				2011/05/22	2022/03/28
Edurant FDA Approved HIV Treatment	U.S. Food and Drug Administration				2011/05/20	2022/03/29
FDA Approves Victrelis for Hepatitis C	U.S. Food and Drug Administration				2011/05/14
FDA Approves Tradjenta (linagliptin) for Treatment of Type 2 Diabetes	FDA Approvals				2011/05/03
Horizant for Restless Legs Syndrome FDA Approved	U.S. Food and Drug Administration				2011/04/10
FDA Proposes Draft Menu and Vending Machine Labeling Requirements	U.S. Food and Drug Administration				2011/04/01
Yervoy Ipilimumab Treatment for Late Stage Skin Cancer	U.S. Food and Drug Administration				2011/03/28	2022/05/02
Zostavax Vaccine to Prevent Shingles - FDA Approval	U.S. Food and Drug Administration				2011/03/25
FDA Approves Edarbi for High Blood Pressure	U.S. Food and Drug Administration				2011/02/26	2022/05/22
Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS	Neuralstem, Inc.				2011/02/14
FDA Approves Viibryd to Treat Major Depressive Disorder	U.S. Food and Drug Administration				2011/01/22
Natroba (Spinosad) Head Lice Treatment for Children and Adults - FDA Approval	U.S. Food and Drug Administration				2011/01/18
FDA Warns Consumers Not to Use Fruta Planta Weight Loss Products	FDA				2011/01/01
Extension of FDA Review for Cladribine Tablets for Treatment of Relapsing Forms of Multiple Sclerosis	EMD Serono, Inc.				2010/11/26	2017/02/13
FDA Approves Cymbalta for Chronic Musculoskeletal Pain	Eli Lilly and Company				2010/11/07
FDA Approval of First Drug to Treat Tuberous Sclerosis Complex	Tuberous Sclerosis Alliance				2010/10/30	2017/06/26
PRADAX Approved for for Stroke Prevention in Canadians with Atrial Fibrillation	BOEHRINGER INGELHEIM				2010/10/27
New Oral Contraceptive Also Raises Folate Levels	Bayer HealthCare Pharmaceuticals Inc.				2010/09/25
Oral Drug to Reduce MS Relapses FDA Approved	U.S. Food and Drug Administration				2010/09/22
FDA Approves Krystexxa for Treatment-Resistant Gout	U.S. Food and Drug Administration	Yes	✓ Preface ✓ Postface	Announcement	2010/09/15	2025/05/27
FDA Approves Pediatric Use of Chemical Poisoning Treatment	U.S. Food and Drug Administration				2010/09/09
Actavis Receives FDA Approval of Atomoxetine HCl Capsules for ADHD	Actavis Inc.				2010/09/02
FDA Approves Ella Abortion Drug as Emergency Contraceptive	Family Research Council	Yes		Announcement	2010/08/15	2024/06/14
Public Outcry for FDA Reform	Ian C. Langtree				2010/08/13	2022/03/22
FDA Approves Vaccines for 2010-2011 Influenza Season	U.S. Food and Drug Administration				2010/07/31
New York State Approves Quest Diagnostics Fragile X Syndrome Test	Quest Diagnostics				2010/07/30
Implantable Miniature Telescope Improves Sight of AMD Patients	U.S. Food and Drug Administration				2010/07/08
Circadin Approved in EU for Treatment of Primary Insomnia	Neurim Pharmaceuticals LTD				2010/07/05
FDA Approves New Treatment for Advanced Prostate Cancer	U.S. Food and Drug Administration				2010/06/18
FDA Clearance of Lactate Test	Epocal, Inc.				2010/06/15
FDA Advisory Committee Recommends Approval of FTY720 Fingolimod for Relapsing Remitting Multiple Sclerosis	Novartis Pharmaceuticals Corporation				2010/06/12
FDA to Review Dental Amalgam	U.S. Food and Drug Administration				2010/06/10
FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women	U.S. Food and Drug Administration				2010/06/01
LensAR Laser System Receives FDA Clearance for Use in Cataract Surgery	LensAR, Inc.				2010/05/18
FDA Clearance for Redsense Safety Device for Home use During Home Hemodialysis	Redsense Medical AB				2010/05/18
Equal Rigor in Assessing Food Claims and Drug Approvals	Institute of Medicine (National Academy of Medicine)	Yes		Informative	2010/05/12	2024/09/03
U.S. FDA Approves Natazia, a New Oral Contraceptive for the Prevention of Pregnancy	Bayer HealthCare Pharmaceuticals Inc.				2010/05/08
FDA Approves VIMOVO for At-Risk Arthritis Patients	Ian C. Langtree		✓ Preface ✓ Postface	Announcement	2010/05/03	2025/06/27
FDA Approval of Asclera to Treat Varicose Veins	Merz Aesthetics				2010/04/24	2010/05/29
Device Manufacturers to Include Information on Pediatric Populations	U.S. Food and Drug Administration				2010/03/31
FDA Approval of Differin (adapalene) Lotion for Acne Treatment	Galderma Laboratories, L.P.				2010/03/22	2010/06/25

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