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1 Strongbridge Biopharma plc Announces U.S. Food & Drug Administration (FDA) Filing Acceptance of New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome
2 Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations | FDA
3 FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines | FDA
4 FDA In Brief: FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines | FDA
5 Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic | FDA
6 Fulcrum Therapeutics Announces U.S. Food and Drug Administration Grants Fast Track Designation to Losmapimod for the Potential Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)
7 Eagle Hill Expands Healthcare Footprint with Business Transformation Services for US Food and Drug Administration
8 The FDA issues Report Regarding its Oversight Activities
9 FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer
10 FDA Approves Treatment for Chronic Kidney Disease
11 FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov | FDA
12 FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose | FDA
13 Pierre vaccine site ready for children after FDA approval
14 FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers
15 FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker | FDA
16 FDA Must Establish Limits for All Animal Antibiotics
17 Heron Therapeutics Announces US FDA Approval of ZYNRELEF™ (HTX-011) for the Management of Postoperative Pain for up to 72 Hours
18 FDA In Brief: FDA Releases Investigation Report Following 2020 Salmonella Outbreak Linked to Red Onions
19 Quercis Announces Special Protocol Assessment Agreement with US Food and Drug Administration
20 Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | FDA
21 PharmaEssentia Resubmits Application to the U.S. FDA For Ropeginterferon alfa-2b-njft to Treat Polycythemia Vera (PV)
22 FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19 | FDA
23 FDA expected to OK Pfizer vaccine for teens within week
24 Coronavirus (COVID-19) Update: May 11, 2021 | FDA
25 U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Muscle-Invasive Urothelial Carcinoma
26 Neurolutions Receives US Food and Drug Administration De
27 FDA outlines plan for making inspections more consistent going forward
28 Nkarta Receives NKX019 IND Clearance from US Food and Drug Administration for Treatment of Relapsed/Refractory B Cell Malignancies
29 FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients
30 FDA calls for input on peptide evaluation
31 Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency
32 Church & Dwight Initiates Voluntary Recall of Select Vitamins Due to Isolated Manufacturing Issue
33 FDA investigation of 2020 Salmonella outbreak linked to red onions points to irrigation water – Produce Blue Book
34 FDA grants orphan drug designation for Endogena's lead program targeting retinitis pigmentosa
35 FDA Seeks Public Comments on PMI Application to Market IQOS 3 as Modified Risk Tobacco Product
36 FDA Warns Cell Phone, Smart Watch Magnets Affect Medical Devices
37 Are COVID Vaccines FDA Approved? Here's How the Process Works
38 FDA approves J&J Vision's therapeutic contact lenses for myopia
39 Advocates Cheer FDA Review of Abortion Pill Restrictions
40 Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17
41 Coronavirus (COVID-19) Update: May 4, 2021 | FDA
42 7 May 2021 Coronavirus (COVID-19) Update: May 7, 2021 | FDA
43 What difference would full FDA approval make for COVID-19 vaccines?
44 Pfizer aims for full FDA approval of vaccine
45 FDA to start sampling lettuce grown in Salinas Valley, CA – Produce Blue Book
46 Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-605, the First TurboCAR™ Candidate, for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
47 Stop Using This Supplement Immediately, FDA Warns
48 Transplanted Pancreatic Islets: Are They Drugs or Organs?
49 New trial data for Keytruda in triple-negative breast cancer
50 FDA guidance: M9 biopharmaceutics classification system-based biowaive
51 FDA grants fast-track designation to Cerecor's Covid-19 treatment
52 Velvet Ice Cream Recalls Various Products Due to Possible Listeria Risk
53 TÜV SÜD North America Gains U.S. FDA (Food & Drug Administration) ASCA Accreditation for Medical Device Testing
54 Coronavirus (COVID-19) Update: April 16, 2021 | FDA
55 FDA grants EUA to Qiagen's digital SARS-CoV-2 antibody test
56 Coronavirus (COVID-19) Update: April 27, 2021 | FDA
57 Hand sanitizer recall: FDA says Medically Minded brand found to contain methanol
58 Hershey Voluntarily Recalls Hershey's Chocolate Shell Topping Due to Undeclared Almonds
59 FDA Puts Investigational FSHD Therapy Losmapimod on Fast Track
60 New FDA Program Could Help Standardize Regulatory Submissions
61 BridgeBio Pharma Receives FDA Fast Track Designation for Investigational Gene Therapy for ...
62 Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand Organic Black Beans, and O Organic Brand Black Beans and O Organic Brand Chili Beans Due to Compromised Hermetic Seal
63 Palisade Bio Receives FDA Fast Track Designation for LB1148
64 Novavax begins vaccinating children in trial at University of Maryland School of Medicine
65 City of St. Louis Teenagers Become Eligible For COVID-19 Vaccines
66 Sara Lee Frozen Bakery Issues Allergy Alert on Undeclared Peanuts in Pecan Pies
67 Cannabis firms ready FDA ingredient notifications with eye on legalization
68 Coronavirus (COVID-19) Update: April 20, 2021
69 Global Sanitizers Issues Voluntary Nationwide Recall of Medically Minded Hand Sanitizer Due to Presence of Undeclared Methanol
70 Johnson & Johnson Vision Announces FDA Approval of ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management
71 Jule's Foods Issues Voluntary Recall of Jule's Foods Products Because of Possible Health Risk
72 Hanmi's lung fibrosis drug candidate wins FDA orphan drug status
73 Biogen's experimental eye treatment fails to meet study goal
74 ZOLL Medical Receives FDA IDE Approval for Initiation of ISO SHOCK (Incorporating Supersaturated Oxygen in Shock) Feasibility Study
75 First Genetically Modified Mosquitoes Released in U.S. Are Hatching Now
76 Dash Xclusive Issues Voluntary Nationwide Recall of Imperia Elita Vitaccino Coffee Due to the Presence of Undeclared Sibutramine and Fluoxetine
77 Ex-FDA Chief Sees 'Struggle' To Vaccinate More Than Half U.S. Population
78 Metro Nashville Public Schools partners with Vanderbilt to get kids ages 12-15 vaccinated
79 Vaccinations for youth 12 and above expand on Maui
80 Faron sub-licenses US rights to traumakine patent
81 QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies
82 SCYNEXIS Secures Term Loan Facility for up to $60 Million
83 Emergent Bio Execs to Testify Before Congress Following Vaccine Manufacturing Mistake
84 Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
85 argenx Reports First Quarter 2021 Financial Results and Provides Business Update
86 Applied DNA Provides Clarification on Newly Authorized Asymptomatic Serial Screening Indication for LineaTM COVID-19 Assay Kit and Press Release Published 12 May 2021
87 Palatin Hosting Key Opinion Leader Webinar in Role of Melanocortin Agonists in Inflammation and the Treatment of Ocular Indications
88 Praxis Precision Medicines Prices Public Offering of Common Stock
89 FDA Grants EUA to Applied DNA LineaTM COVID-19 Assay Kit for Asymptomatic Screening of Individuals with Serial Testing
90 J&J COVID-19 vaccine manufacturing halted at U.S. plant that had contamination issue
91 Long Beach will start vaccinating kids ages 12+ starting Thursday
92 Antengene Announces IND Approval in China for a Global Phase III Trial of Selinexor in Advanced or Recurrent Endometrial Cancer
93 Hemp in Onslow, Part One: Intro to Hemp and CBD, a potential medicine for veterans
94 CBD tablet significantly improves diabetic peripheral neuropathic pain
95 Guan's Mushroom Co Recalls Enoki Because of Possible Health Risk
96 Desktop Health Receives FDA Clearance for Flexcera for Next Generation 3D Printed Dentures
97 Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants | FDA
98 FDA Approves First Treatment for COVID-19 FDA approved Veklury
99 FDA Takes Actions to Help Lower US Prescription Drug Prices | FDA
100 FDA, Mexican Counterparts Enhance Food Safety Partnership | FDA