FDA Related News

Federal Register

FDA Revokes 5 Covid Test EUAs

Federal Register notice: FDA is revoking the emergency use authorizations on five no-longer-marketed Covid-19 tests.

Human Drugs

Pazdur et al Weigh Challenges with PI3K Inhibitors

Writing in an online Lancet Oncology article, FDA officials outline challenges with current PI3K inhibitors that have the agency reconsidering how the...

Diversity Plans Needed Before Phase 3: Law Firm

A Hogan Lovells analysis of FDAs recent guidance on clinical trial diversity plans says such plans should be an important part of drug and device deve...

Human Drugs

Nektar, BMS Nix Opdivo/Bempegaldesleukin Trials

Nektar Therapeutics and Bristol Myers Squibb end their clinical development program for bempegaldesleukin in combination with Opdivo (nivolumab) for t...

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 4/15/2022.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Human Drugs

Ukoniq Withdrawn Due to Overall Survival Concerns

Due to overall survival concerns, TG Therapeutics withdraws its accelerated approval of Ukoniq (umbralisib), a PI3K inhibitor for treating adults with...

Human Drugs

Hiers Enterprises Hit With 483 After Inspection

FDA issues Hiers Enterprises (dba Northwest Compounding Pharmacy) a Form FDA-483 after inspecting the firm in 11/2021.

Human Drugs

aTyr Pharma Gets Orphan Status on Efzofitimod

FDA grants aTyr Pharma an orphan drug designation for efzofitimod and its use in treating systemic sclerosis.

Biologics

Amneal BLA for Avastin Biosimilar Approved

FDA approves an Amneal Pharmaceuticals BLA for bevacizumab-maly, a biosimilar referencing Genentechs Avastin.