The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. Pfizer Inc.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] June 2019). 1] It is taken by mouth. [1] 20 (4): 413–420. 2017.03.007.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. There are limited clinical data available for baricitinib use in coronavirus 2019 (COVID-19). It is approved in the U.S. It is approved in the U.S.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. Securities and Exchange Commission , including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020.

Production 40

Production Trials Treatment Pharmaceuticals 40

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Global Head, Janssen Research & Development, Johnson & Johnson. Use in Specific Populations.

FDA Approval 52

FDA Approval Treatment RNA FDA 52