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1 FDA Takes Actions to Help Lower US Prescription Drug Prices
2 FDA Requiring Labeling Changes for Benzodiazepines
3 FDA Launches the Digital Health Center of Excellence
4 US Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
5 AbbVie Receives Orphan Drug and Fast Track Designations from the US Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury
6 FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety
7 FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
8 FDA Warns Website Operators Illegally Selling Opioids to Consumers
9 Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19
10 Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
11 FDA Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish Trade with Europe for the First Time in 10 Years
12 FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
13 FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
14 NanoVibronix UroShield® Receives US Food and Drug Administration Authorization for Entry into the US
15 US Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)
16 The US Food and Drug Administration warns of the dangers of...
17 Nucala, GSK drug, receives FDA approval to treat HES
18 National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
19 Mallinckrodt Receives a Complete Response Letter from the US Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
20 US Food and Drug Administration Selects Cambridge Semantics for Data and Analytics Platform
21 Alphamab Oncology announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to KN046 for the treatment of thymic epithelial tumor
22 FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices
23 Ascendis Pharma A/S Announces US Food and Drug Administration (FDA) Accepts Biologics License Application (BLA) for TransCon™ hGH for Pediatric Growth Hormone Deficiency (GHD)
24 FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
25 Food Safety Determinations Trade of Molluscan Shellfish
26 Seres Therapeutics Announces U.S. Food and Drug Administration Correspondence Following Positive SER-109 Phase 3 Study Results
27 Kite Submits Supplemental Biologics License Application to US Food and Drug Administration for Yescarta® in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas | DNA RNA and Cells | News Channels
28 U.S. FDA pauses Inovio's coronavirus vaccine trial plan
29 Liminal BioSciences Announces Resubmission of Biologics License Application to US Food and Drug Administration for Ryplazim® (plasminogen) for Treatment of Congenital Plasminogen Deficiency
30 Sunshine Mills, Inc. Issues Voluntary Recall of Certain Dog Food Products Due to Potentially Elevated Levels of Aflatoxin
31 Aerie Pharmaceuticals Announces U.S. Food and Drug Administration Approval of its Athlone, Ireland Facility for Production of Rhopressa® (netarsudil ophthalmic solution) 0.02%
32 Aquestive CRL sends shares plummeting
33 Real Pet Food Company of Phoenix, AZ Voluntarily Recalls One Lot of Billy+Margot Wild Kangaroo and Superfoods Recipe Dog Food in 4 lb Bags Because of a Possible Salmonella Health Risk (USA)
34 Coronavirus (COVID-19) Update: Daily Roundup September 24, 2020
35 Gilead, Galapagos arthritis drug rejected by FDA gets go-ahead from Japanese, European regulators
36 FDA Approves Therapy for Hospital-Based Bacterial Pneumonias
37 U.S. Food and Drug Administration Approves Onureg® (azacitidine tablets), a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
38 FDA issues Benadryl warning as it investigates reports of injuries, deaths linked to TikTok challenge
39 Coronavirus (COVID-19) Update: Daily Roundup September 25, 2020
40 HHS Issues Certification for Canadian Drug Imports
41 Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency
42 FDA willing to fast track coronavirus vaccine before phase three trials end
43 FDA approves new Baxter clinical nutrition injections
44 FDA considering authorization rules that could push coronavirus vaccine past Election Day
45 xCures announces the launch of a Compassionate Use program for ulixertinib (BVD-523)
46 FDA Coronavirus (COVID-19) Update: September 27th, 2020
47 Quotient Limited Announces Receipt of US FDA Emergency Use Authorization (EUA) for MosaiQ COVID-19 Antibody test
48 FDA Issues Intended Use Proposed Rule
49 FDA Reissues Emergency Use Authorization for Hologic SARS-CoV-2 Assay for Asymptomatic Testing
50 Khondrion Receives Rare Pediatric Disease Designation for Sonlicromanol from US FDA
51 Gilead's Investigational Antiviral Veklury® (Remdesivir) Receives US Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19 | Small Molecules | News Channels
52 Precision BioSciences Receives Fast Track Designation from U.S. Food and Drug Administration for PBCAR269A, an Investigational Allogeneic CAR T Therapy for Relapsed/Refractory Multiple Myeloma
53 Import Screening Pilot Unleashes the Power of Data
54 Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
55 Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020
56 ADC Therapeutics Submits Biologics License Application to the US Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
57 CSL_Behring_Logo.jpg | |
58 Justification for Stricter Standards Sought
59 Smartphone Biosensor May Meet ISO/FDA Standard for Pulse Oximetry Monitoring
60 Lack of Key Considerations in FDA Food Chemical Safety Process Leaves Consumers at Risk of Chronic Diseases
61 Masimo Rad-G pulse oximeter gets FDA clearance
62 FDA Coronavirus (COVID-19) Update: September 26th, 2020
63 Here's how Trump could bigfoot the FDA and get a vaccine out ahead of the science
64 Angle Files De Novo FDA Submission for CTC Collection Device in Breast Cancer
65 LG Chem's obesity treatment wins ODD status in US
66 Drug prices: Why prescription medicines are unaffordable for many people
67 Unprecedented Global Turmoil Underlines Need for Effective Diagnostics
68 A 'Dangerous Season' Ahead: Gottlieb Raises Concern Over Rising COVID-19 Numbers
69 Trump Administration To Allow Importation Of Prescription Drugs
70 Novel compounds show efficacy against C. diff
71 SHAREHOLDER ALERT: BioMarin Pharmaceutical, Inc. Sued for Violations of the Federal Securities Laws; Investors Who Lost Money Should Contact Block & Leviton LLP
72 Genetic Testing Cost Effective for Newly Diagnosed GIST
73 Stocks Moving Premarket Monday: Uber, Devon Energy
74 Trump puts pressure on FDA for coronavirus silver bullet ahead of Election Day
75 Roche's Evrysdi improves motor functions in infants with SMA
76 Basilea Awarded Additional Funding from US Medical Countermeasure Program for Ceftobiprole Development
77 COVID-19 Weekly Newsletter: Case Count, Death Toll Both Rising as Public Health Officials Work to Instill Confidence in a Vaccine
78 Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
79 Medtronic secures favourable decision in patent dispute
80 New York City cases still 'alarming' in some areas
81 Apollomics, Inc. Receives China Investigational New Drug Approval for APL-106 to Initiate a Phase 3 Bridging Study in Acute Myeloid Leukemia
82 New York Sees Uptick; Global Death Milestone Nears: Virus Update
83 FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
84 Pre-Open Stock Movers 09/28: (PLL) (PRCP) (GNFT) Higher; (INO) (AQST) (VIPS) Lower (more...)
85 ENR Highlights CRB's Work in Plant-Based Foods – Press Releases on
86 Wismettac Asian Foods Voluntarily Recalls Dried Fungus Due to Potential Salmonella Contamination
87 Are CBD Labels Accurate? Too Many Brands Are Misleading Consumers, Studies Show
88 COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
89 AVROBIO Receives Orphan Drug Designation from the European Medicines Agency for AVR-RD-02, an Investigational Gene Therapy for Gaucher Disease
90 FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings
91 Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
92 Montco company’s COVID-19 vaccine trial on hold; Fauci warns U.S. is ‘not in a good place’; CDC suggests avoid
93 FDA Approves Oral Treatment for Spinal Muscular Atrophy
94 Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
95 EQUITY ALERT: Rosen Law Firm Announces Filing of Securities Class Action Lawsuit Against BioMarin Pharmaceutical Inc. – BMRN
96 Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
97 Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests
98 USDA, FDA Strengthen US Food Supply Chain Protections
99 Eiger Announces Results of Investigator Sponsored Study in Outpatients with Mild and Uncomplicated COVID-19
100 How Proposition EE would change the tax on cigarettes, vapes in Colorado