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1 FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional
2 FDA Approves New HIV Treatment for Patients With Limited Treatment Options
3 FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
4 Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use
5 FDA Approves New Therapy for Dravet Syndrome
6 Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
7 Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
8 FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials
9 FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer
10 Coronavirus (COVID-19) Update: Daily Roundup June 29, 2020
11 Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19
12 Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
13 Coronavirus (COVID-19) Update: Daily Roundup July 1, 2020
14 FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening
15 FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic
16 FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord
17 FDA Approves Drug to Treat Infants and Children with HIV
18 Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19
19 Coronavirus (COVID-19) Update: FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts
20 Coronavirus (COVID-19) Update: Daily Roundup June 23, 2020
21 FDA Maintains Its Goals on Applications for Medical Products
22 Coronavirus (COVID-19) Update: Daily Roundup June 26, 2020
23 Cancer Trial Data Will Be Shared in FDA's New Project Patient Voice
24 Coronavirus (COVID-19) Update: Daily Roundup June 19, 2020
25 Coronavirus (COVID-19) Update: Daily Roundup June 25, 2020
26 Coronavirus (COVID-19) Update: Daily Roundup June 22, 2020
27 Norpac Fisheries Export Recalls Shrimp Poke Due to Possible Health Risk
28 No Read-Through Expected: NASH Field Unfazed By Intercept's FDA Rejection
29 Coronavirus (COVID-19) Update: Daily Roundup June 12, 2020
30 The J. M. Smucker Company Issues Voluntary Recall of One Lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula Canned Cat Food
31 Coronavirus (COVID-19) Update: Daily Roundup June 8, 2020
32 Alls not well with the State FDA (Food and Drug Administration)
33 Fresh Express Issues a Precautionary Recall of Products Containing Iceberg, Red Cabbage and Carrots Produced at its Streamwood, IL Facility Due to a Potential Cyclospora Risk
34 Rare Disease Therapy Development and Access Remain Top FDA Priorities
35 Ultragenyx scores 2nd FDA approval in as many weeks for ultra-rare metabolic disease drug Dojolvi
36 Coronavirus (COVID-19) Update: Daily Roundup June 17, 2020
37 UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
38 Coronavirus (COVID-19) Update: Daily Roundup June 18, 2020
39 FDA blasts California compounding pharmacy for facility 'contaminated with filth'
40 Federal Government Announces New Pilot Program to Help Stop Illegal Availability of Unapproved Opioids Online
41 FDA Approves First Treatment for Adult Onset Still's Disease, a Severe and Rare Disease
42 FDA Approves Phesgo for HER2-Positive Breast Cancer
43 Kroger secures FDA authorization for at-home coronavirus test kit
44 Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling
45 Coronavirus (COVID-19) Update: Daily Roundup June 11, 2020
46 Partnering with the European Union and Global Regulators on COVID-19
47 FDA drug Remdesivir headed to 12 San Antonio-area hospitals
48 FDA Covid Vaccine Guidance Throws Cold Water on Trump 2020 Goal
49 Salad Supplier Recall Expanded after Potential Cyclospora Contamination; Hy-Vee Pulls Additional Salads as a Result
50 Israeli medical company receives FDA approval for life-saving tech
51 FDA rejects Intercept Pharma's drug for fatty liver disease
52 Top FDA Recalls: Mystic Shield Protection Topical Solution, Pasta With Listeria Risk
53 Garland Ventures LTD Voluntary Recalls Five Cheese Stuffed Shells Because of Possible Health Risk
54 GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings
55 FDA adds oropharyngeal cancer prevention as indication for HPV vaccine
56 Prescribers Should Restrict the Use of Non-FDA-Approved Compounded Bioidentical Hormones, Except for Specific Medical Circumstances
57 FDA Requests More Non-Clinical Information for HTX-011
58 Acacia Pharma Announces US FDA Approval of BYFAVO™ (remimazolam) for injection for the Induction and Maintenance of Procedural Sedation
59 FDA approves 'prescription video game' for kids with ADHD
60 FDA minister warns Patanjali: No false claims
61 The FDA's gay and bi blood-donor ban isn't just stigmatizing—it's also likely outdated
62 5 FDA COVID-19 Decisions in July Could Make or Break Stocks
63 FDA APPROVED KN95 Face Masks
64 Kroger gets FDA approval for at-home COVID-19 test
65 Qualigen Therapeutics Submits Notification to FDA to Commence Distribution of its FastPack® COVID-19 Antibody Test
66 9 Hand Sanitizers May Be Toxic, F.D.A. Warns
67 Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produced by Eskbiochem SA de CV Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
68 Axonics obtains FDA approval for 3T full-body MRI scans
69 Transliquid Technologies LLC Issues Voluntary Recall of Mystic Shield Protection Topical Solution Due to Presence of Undeclared Methanol for the States of California, Louisiana, Massachusetts, and Texas
70 S. Korea's first antibody test kit ACCEL ELISA COVID-19 wins FDA EUA
71 How The FDA Approved A Startup To Collect Coronavirus Samples At Home In 8 Weeks
72 FDA Solicits Comments on Pediatric Codeine Use, Role of Genetic Testing
73 FDA approvals roundup: Zogenix's Fintepla, Ultragenyx's Dojolvi, and Genentech's Phesgo
74 The likely heir to an FDA powerbroker brings expertise — and controversy
75 In Association with Fresh Express Inc., ALDI Voluntarily Recalls Little Salad Bar Garden Salad
76 FDA Commissioner Hahn and Deputy Shah: Coronavirus vaccine search – here’s what we’re doing to defeat COVID-19
77 US hits another bleak coronavirus milestone while FDA chief is 'cautiously optimistic' about finding vaccine
78 FDA approves four new Cochlear products
79 FDA issues final guidance on inspections of medical device establishments
80 FDA Rejects Intercept’s Liver Disease Drug, But This Analyst Still Anticipates Approval
81 FDA Approves Medtronic's Percept PC Deep Brain Stimulation System
82 Eye Inflammation Dooms AbbVie Wet AMD Drug to an FDA Rejection
83 Dupilumab pre-filled pen approved by FDA
84 Fresh Express Voluntarily Issues Recall of Limited Quantity of Marketside Classic Iceberg Salad
85 FDA reports on drug quality, oversight trends in FY2019
86 FDA: Streamwood Facility 'Likely Cause' of Foodborne Illness Linked to Salads
87 Qure.ai's head CT scan product gets US FDA nod
88 FDA OKs Octreotide Capsules; COVID-19 Damages Endocrine System
89 FDA signs MoU with NBSSI to support growth of MSMEs
90 Insight into FDA's Revised Policy on Antibody Tests for COVID-19
91 Azar, Trump Mislead on FDA's Hydroxychloroquine Decision
92 BRIEF-Paion: US FDA Approval Of Remimazolam For Induction And Maintenance Of Procedural Sedation
93 COVID: FDA WARNS OVER METHANOL IN HAND SANITIZERS
94 Recon: Gilead sets US remdesivir price; FDA rejects Intercept NASH drug
95 Fresh Express Announces Precautionary Recall of a Limited Quantity of Southwest Chopped Kit Due to the Presence of Undeclared Allergens
96 New standard of care? FDA hands Pfizer, Merck KGaA an OK for Bavencio in bladder cancer
97 FDA directs private developers to get formal approval
98 Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer
99 Pandemic Highlights Importance of New Era of Smarter Food Safety
100 FDA’s EUA benchmarks for COVID-19 vaccines remain ill-defined: GlobalData