Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. Plus, regulators are promoting this growth. About the authors.

Therapies 246

Therapies Virus Treatment Engineering 246

The Pharma Data

JANUARY 9, 2021

RECONCILIATION OF NON-GAAP MEASURES (unaudited) This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules and regulations.

Government 52

Government Vaccine Production Licensing 52

Agency IQ

MAY 17, 2024

At that time, the FDA would no longer be able to award new vouchers to companies, unless the product already had rare pediatric disease designation, and obtained approval before October 1, 2026. However, the FDA then approved another amifampridine product, Ruzurgi, in 2019 for the treatment of LEMS in pediatric patients.

FDA 40

FDA Disease FDA Approval Production 40

The Pharma Data

NOVEMBER 4, 2020

Securities and Exchange Commission Regulation G. VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. 1 (908) 892-2028 PR@amarincorp.com (media inquiries). .

Production 40

Production FDA Trials Licensing 40