January 25, 2021

Novel Drug Approvals for 2018

No. DrugName Active Ingredient Approval Date FDA-approved use on approval date* 59. Ultomiris ravulizumab 12/21/2018 To treat paroxysmal nocturnal hemoglobinuria (PNH)Press ReleaseDrug Trials Snapshot 58. Elzonris […]
January 22, 2021

Coronavirus (COVID-19) Update: January 22, 2021

For Immediate Release: January 22, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
January 22, 2021

April – June 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Aimovig (erenumab-aooe) Wrong strength FDA decided that no action is necessary at this time based on available information. Aimovig (erenumab-aooe) Product preparation error FDA is evaluating […]
January 22, 2021

FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma

On January 22, 2021, the Food and Drug Administration approved  the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for […]
January 22, 2021

Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA

These tables provide the current number of Drug Development Tool (DDT) projects grouped overall, by Program, and DDT stage. Please note, the stage of the DDT […]
January 22, 2021

Getting it Right: Retention Samples for BA and BE Studies – 03/19/2021 – 03/19/2021

On This Page Date: March 19, 2021 Time: 1:00 PM – 2:00 PM ET This webinar is FREE. This webinar is intended to help applicants submitting […]
January 21, 2021

Types of Drug Master Files (DMFs)

Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product The Generic Drug User Fee Amendments (GDUFA) include provisions for […]
January 21, 2021

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

For Immediate Release: January 21, 2021 The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the […]
January 21, 2021

Orange Book Preface

Food and Drug AdministrationCenter for Drug Evaluation and ResearchApproved Drug Products with Therapeutic Equivalence Evaluations The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, […]
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