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FDA Approval
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FDA New Drug Approvals
Many First-in-Class Drugs Approved by FDA in 2022, but Overall Approval Numbers Down
PAO-03-23-NI-03
Column: Clinical Trials
CAR-T Study Shines New Spotlight on Clinical Trials Representation
PAO-06-022--NI-06
Column: New Drug Watch
New Drug Watch: A Validation of the ‘Twincretin’ Approach to Type 2 Diabetes
PAO-06-022--NI-08
Column: New Drug Watch
Alzheimer Drug Still Controversial
PAO-03-022-NI-04
COVID-19 Vaccine
FDA Approves SPIKEVAX®, Moderna's mRNA COVID-19 Vaccine
PR-M02-22-01
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
FDA Approval
Blueprint Medicines Announces FDA Approval of GAVRETO™ (pralsetinib) for the Treatment of Patients with Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancer
PR-M11-20-027
Antibodies
Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19
PR-M11-20-023
FDA Approval
FDA Approves First Treatment for Ebola Virus
PR-M10-20-10
Opioid
Trevena Announces FDA Approval of OLINVYK Injection
PR-M08-20-NI-30
FDA Approval
FDA Approves GSK’s BLENREP for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
PR-M08-20-NI-11
COVID-19 Treatment
Common FDA-Approved Drug May Effectively Neutralize Virus That Causes COVID-19
PR-M07-20-NI-32
Nice Insight Overview
Drug Approval Trends: Significant Acceleration in Recent Years
PAP-Q2-20-NI-001
FDA Approval
FDA Approves First-Of-Its-Kind Percep PC Neurostimulator with BrainSense Technology
PR-M06-20-NI-037
FDA Approval
FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
PR-M06-20-NI-021
FDA Approves GSK's Zejula
PR-M05-20-NI-014
FDA Approval
Novartis Announces FDA Approval of MET Inhibitor Tabrecta™ for Metastatic Non-Small Cell Lung Cancer with METex14
PR-M05-20-NI-011
FDA Approval
FDA Approves New Meningococcal Vaccination
PR-M04-20-NI-041
COVID-19 At-Home Testing
FDA Authorizes First Test for Patient At-Home Sample Collection
PR-M04-20-NI-037
FDA Approval
Roche Receives FDA Approval for Cobas HPV Test to Identify Women at Risk for Cervical Cancer
PR-M04-20-NI-031
Priority Review
FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola
PR-M04-20-NI-025
FDA Approval
Perrigo and Catalent Announce FDA Approval of Perrigo's AB-Rated Generic Version of ProAir® HFA
PR-M02-20-NI-041
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