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1 Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home
2 Coronavirus (COVID-19) Update: November 3, 2020
3 FDA Approves First Drug to Treat Rare Metabolic Disorder
4 Coronavirus (COVID-19) Update: November 24, 2020
5 FDA authorizes new Covid-19 antibody test that quantifies specific levels of antibodies
6 Coronavirus (COVID-19) Update: November 23, 2020
7 FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
8 Azar says vaccine distribution could begin within weeks, pending FDA approval
9 COVID-19 Update
10 Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
11 Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators
12 Shenandoah Growers Inc Issues a Limited, Voluntary Recall of Certain Imported Organic Basil Because of Potential Health Risk
13 Why the United States-Mexico-Canada Agreement is Important to FDA
14 FDA Approves Y-mAbs' DANYELZA® (naxitamab-gqgk) for the Treatment of Neuroblastoma
15 The FDA has approved the first drug to treat the rapid-aging disease progeria
16 Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
17 FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies
18 FDA Approves A Drug For A Rare Disease That Causes Children To Age Quickly : Shots
19 These FDA-approved KN95 masks are on sale for just $2 a pop at Amazon
20 FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults
21 Pfizer Applies for Emergency F.D.A. Approval for Covid-19 Vaccine
22 Eli Lilly Antibody Treatment For The Coronavirus Gets FDA's OK For Emergency Use : Shots
23 Dole Fresh Vegetables Announces Limited Recall of Organic Romaine Hearts
24 Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
25 Is the FDA's guidance on FDAAA 810 adequate to ensure compliance?
26 FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs
27 Final FDA Guidance Reinforces Increased Focus On Diversity And Inclusion In Clinical Development
28 Prairie Farms Issues Allergy Alert on Undeclared Egg in Chocolate Milk Gallons
29 When might a COVID-19 vaccine be authorized? FDA Commissioner Stephen Hahn answers common questions
30 Coronavirus (COVID-19) Update: November 13, 2020
31 Senhwa Announces Multiple IND Application Submissions to US FDA and Health Canada for the Treatment of Solid Tumors with BRCA2 or PALB2 Mutations
32 Coronavirus (COVID-19) Update: November 16, 2020
33 Watch now: Fortenberry talks about virus vaccine with FDA chief
34 FDA Approves Lotion for Nonprescription Use to Treat Head Lice
35 Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements
36 Decades of NIH research help lead to first FDA-approved treatment for progeria
37 Ten Urgent Reforms To Protect The CDC And FDA From Harmful Political Interference
38 US FDA grants emergency use authorization to Regeneron COVID-19 antibody given to Trump
39 Coronavirus (COVID-19) Update: October 28, 2020
40 Merck submits 15-valent pneumococcal vaccine candidate to EMA and FDA
41 Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection
42 Roche's Xofluza gets FDA approval for influenza prevention
43 FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities
44 5 most unusual treatments approved by the FDA
45 FDA clears Baxter's virtually connected, in-home peritoneal dialysis system
46 Anthony Fauci calls on New York to accept FDA approval of vaccine
47 Covid-19 vaccine submitted to FDA for emergency use authorization
48 Arca Biopharma gets fast-track approval from FDA for potential Covid-19 treatment
49 FDA Announces Availability Of The Standard Memorandum Of Understanding For Signature By States – The 365 Day Countdown To 5% Begins
50 Coronavirus (COVID-19) Update: October 30, 2020
51 FDA Releases New Outbreak Investigation Table
52 The 'very, very bad look' of remdesivir, the first FDA-approved COVID-19 drug
53 Hy-Vee Voluntarily Recalls Two Short Cuts Vegetable Mix Products Because of Possible Health Risk
54 FDA Says WHO's Trial On Covid Drug Doesn't Refute Its Findings
55 Listen: Pfizer's Covid-19 vaccine data & the FDA's Alzheimer's quandary
56 Romaine in at least 15 states voluntarily recalled over possible E. coli risk, FDA says
57 Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination
58 Surgical Robots Market: FDA-approved Surgical Robots Gain Prominence in Gynecological Surgeries
59 Statutory deadline for OTC hearing aid rule missed by FDA
60 FDA: Face, surgical masks may still offer protection even after its expiration date
61 AliveCor, which helps its users manage their heart health, scores another FDA approval
62 Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine
63 FDA grants food industry flexibility on ingredient labels; consumers, medical professionals express concern
64 Fresh Express Recalls Limited Quantity of Expired Fresh Express Kit Caesar Supreme Due to Potential Health Risk
65 FDA Accepts Invitae Premarket Approval Submission for Stratafide Companion Diagnostic
66 NCLA Brief Asks DC Circuit to Stop FDA's Improper Attempt to Regulate the Practice of Medicine
67 ELITechGroup MDx Submits SARS-CoV-2 Plus ELITe MGB Assay to FDA
68 FDA Approves First Drug For Rare, Rapid-Aging Genetic Disorder
69 PRA Health taps senior FDA officials to lead push into remote trials
70 F.D.A. Authorizes the First At-Home Coronavirus Test
71 Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella
72 FDA commissioner says agency will strike a balance in reviewing vaccine applications
73 FDA Approvals Roundup | RAPS
74 F.D.A. Panel Declines to Endorse Controversial Alzheimer’s Drug
75 Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
76 WHO backs off on remdesivir as FDA issues another EUA
77 Dog food recalled over salmonella concerns, FDA says
78 Eli Lilly’s Antibody Treatment Gets Emergency F.D.A. Approval
79 FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety
80 The FDA's cutoff for Covid-19 vaccine effectiveness is 50 percent. What does that mean?
81 HHS Instructs FDA to Resume Review of EUA Submissions for SARS-CoV-2 LDTs
82 FDA and Pharmacy Weekly Digest
83 After Rocky Start, FDA’s Hahn Wins Over Skeptics
84 PD-L1 IHC 22C3 pharmDx Gets FDA Approval as Companion Diagnostic for Pembrolizumab in Breast Cancer
85 COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
86 FDA Approves First Treatment for COVID-19
87 MedWatch
88 Coronavirus Roundup: HHS Cancels Celebrities Campaign; FDA Approves First Rapid At-Home COVID-19 Test
89 Updated: FDA gives Cellectis all clear after patient death halted off-the-shelf CAR-T trial
90 Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
91 FDA Takes Actions to Help Lower US Prescription Drug Prices
92 Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
93 Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products
94 Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19
95 FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
96 FDA Requiring Labeling Changes for Benzodiazepines
97 FDA Approves First Treatment for Ebola Virus
98 COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
99 FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
100 Emily Miller and Another P.R. Expert Ousted At F.D.A. After Blood Plasma Fiasco