Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.

Articles

The first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years launched in the United States in November 2021 after being approved in August 2020.

First-in-Class Topical Treatment Clascoterone Launches in US to Treat Acne Vulgaris

Daridorexant belongs to a class of drugs known as a dual orexin receptor antagonists.

Daridorexant Approved for Adults With Insomnia

Cullinan Oncology’s CLN-081 today received a Breakthrough Therapy Designation from the FDA for the treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC). 

CLN-081 Receives Breakthrough Therapy Designation for NSCLC

Despite being the seventh adalimumab biosimilar approved in the United States, there are none on the market yet.

Yusimry, the Seventh Adalimumab Biosimilar, Gains FDA Approval

The FDA this week approved cabotegravir (Apretude), the first and only long-acting injectable pre-exposure prophylaxis option to reduce the risk of sexually acquired HIV-1.

FDA Approves Long-Acting, Injectable Cabotegravir to Prevent HIV

Secukinumab is approved for use among patients with enthesitis-related arthritis (ERA) aged 4 years and up, and those with psoriatic arthritis (PsA) who are at least 2 years old.  

Secukinumab Approved for Pediatric Patients With ERA, PsA

Up to 500 million at-home COVID-19 test kits will be sent to US households for free, by request; Biogen cut the price of its Alzheimer disease drug Aduhelm nearly in half; the FDA approved the world’s first injectable medication to reduce the risk of sexually transmitted HIV.

What We’re Reading: Free At-Home COVID-19 Tests; Aduhelm Price Cuts; First Injectable HIV Preventive

FDA Approves Tezepelumab for Severe Asthma

The oral polymerization inhibitor, a first-in-class therapy for sickle cell disease,  was first approved by the FDA for adults and pediatric patients 12 years of age and older in 2019.



Voxelotor for Sickle Cell Disease Wins FDA Nod for Patients as Young as 4

The FDA approved FoundationOneCDx as the first companion diagnostic for current and future BRAF inhibitor therapeutics used to treat melanoma, including both monotherapies and combination therapies.