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© 2022 MJH Life Sciences™ and Clinical Care Targeted Communications, LLC. All rights reserved.
The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
January 12, 2022
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.
January 11, 2022
Daridorexant belongs to a class of drugs known as a dual orexin receptor antagonists.
January 04, 2022
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).
December 26, 2021
Despite being the seventh adalimumab biosimilar approved in the United States, there are none on the market yet.
December 24, 2021
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.
December 23, 2021
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.
December 21, 2021
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.
December 17, 2021
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.
December 08, 2021
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.