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Column: Regulatory Spotlight
The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative
PAO-06-022--NI-05
Alzheimer's Diagnostic Test
FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer's Disease
PR-M05-22-02
COVID-19 Breathalyzer Diagnostic
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
PR-M04-22-09
Column: Regulatory Spotlight
New FDA Guidance on Real World Evidence/Real World Data
PAO-03-022-NI-03
Regulatory
FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review
PR-M03-22-03
Drug Update
AbbVie Provides Update Regarding RINVOQ® (upadacitinib) for the Treatment of Moderate to Severe Atopic Dermatitis in the U.S.
PR-M07-21-011
FDA Approval
FDA Grants Accelerated Approval for Aduhelm™ as the First and Only Alzheimer’s Disease Treatment to Address a Defining Pathology of the Disease
PR-M06-21-015
FDA Approval
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
PR-M06-21-008
FDA Approval
Novartis Cosentyx Receives FDA Approval for Treatment of Children and Adolescents with Moderate to Severe Plaque Psoriasis
PR-M06-21-002
COVID-19 Diagnostic
FDA Authorizes First Single-Use, PCR Quality Over the Counter (OTC) LUCIRA CHECK IT™ COVID-19 At-Home Test. Available Now.
PR-M04-21-016
AI
Cosmo Announces Fda Approval of Gi Genius™ Intelligent Endoscopy Module, Its Revolutionary Artificial Intelligence Device for Lesion Detection During Colonoscopy
PR-M04-21-015
FDA Approval
FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival
PR-M04-21-007
FDA Approval
United Therapeutics Announces FDA Approval and Launch of Tyvaso for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
PR-M04-21-003
FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
PR-M11-20-028
FDA Authorization
Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19
PR-M11-20-022
Fast Track
Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer
PR-M11-20-012
Decentralized Trials
Protecting Clinical Research and Patients Through Decentralized Trial Strategies
PAP-Q3-20-CL-025
Oral COVID-19 Vaccine
Vaxart Announces FDA Clearance of IND Application for Oral COVID-19 Vaccine
PR-M09-20-NI-19
FDA Approval
FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
PR-M09-20-NI-04
COVID-19
Gilead’s Remdesivir Receives FDA Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19
PR-M08-20-NI-48
FDA Approval
Cassiopea Receives FDA Approval for Acne Drug
PR-M08-20-NI-44
FDA
FDA Accepts Application for Xolair Prefilled Syringe for Self-Administration Across All Indications
PR-M08-20-NI-32
Diagnostic Testing
FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect COVID-19 Test
PR-M08-20-NI-27
Liquid Biopsy
FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test
PR-M08-20-NI-17
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