Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication. Data on these novel approvals is published throughout the year by both CDER and CBER.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tezepelumab. XmAb is a registered trademark of Xencor, Inc.

Biosimilars 52

Biosimilars Production Treatment FDA 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. That makes Hrymoc a one-off exception from a general exclusion of §510(k) evidence.

Testimonials 105

Testimonials FDA Drugs Vaccine 105