FDA Updates

Our most-read FDA approval articles from 2019. 

Ubrogepant (Ubrelvy) is the first oral calcitonin gene-related peptide receptor antagonist approved by the FDA for the acute treatment of migraine.

Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo and AstraZeneca) is a new treatment option for patients with HER2-positive breast cancer who have progressed after 2 or more prior regimens.

20% subcutaneous immunoglobulin therapy.

Officials with the FDA have approved a new indication and label expansion for icosapent ethyl (Vascepa, Amarin).

Biosimilar to Remicade

Allergan’s positive phase 3 trial results indicate a potential use for the CGRP receptor agonist.

Recent approval under new international Project Orbis.

Ultra-rare, potentially life-threatening genetic disease.

Approved for patients 18 years of age and older

Antibiotic with a novel penetrative mechanism.

Expected U.S. launch in 2023.

First and currently only biological targeting P-selectin.

MCL is an aggressive form of NHL

Shown to reduce regular RBC transfusions in adults with beta thalassemia.

Fourth filgrastim biosimilar from Sandoz, expected ASAP.

Approved for ages 65 and older.

First and currently only rifabutin-based H. pylori therapy approved.

Delayed-release oral capsules for various forms of the disease.

Commercial launch suspended due to manufacturer liquidity.

New formulation improves safety for patients.

Previously approved for IV infusion.

Fourth indication expansion for the 2009 drug.

Reduces risk for heart failure and cardiovascular disease hospitalizations.

Drug able to treat 18,000 people will cost over $300k per year.

Available for prescribing starting January 2020

First approved in 2018 for patients 12 years of age and older.

Originally approved in 1995 for use in adults only.