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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.
May 13, 2022
The treatment was found to improve glycemic control and is indicated to be used in conjunction with diet and exercise.
May 05, 2022
This approval of trastuzumab deruxtecan (Enhertu) follows the March release of data from the DESTINY-Breast03 trial on the anti-HER2 monoclonal antibody, also a HER2-directed antibody-drug conjugate, which indicated superior outcomes vs trastuzumab emtansine.
May 04, 2022
The drug, oteseconazole, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis in females who are infertile or postmenopausal.
April 29, 2022
A new drug has been approved for obstructive hypertrophic cardiomyopathy (HCM); Oklahoma enacts a strict abortion ban; whistleblower claims alarms had been raised about Abbott baby formula contamination.
April 15, 2022
Alymsys from Amneal Pharmaceuticals and mAbxience is the third biosimilar referencing Avastin approved in the United States and the second of 3 biosimilar approvals Amneal expects in 2022.
April 01, 2022
The expanded use of axi-cel, sold as Yescarta, while not unexpected, nonetheless represents uncharted territory in cancer care.
March 28, 2022
The FDA approved a drug to treat a rare form of childhood epilepsy; uninsured Americans will no longer have access to free COVID-19 tests; a conservation group is suing the Environmental Protection Agency (EPA) over failure to protect rivers from pollution.
March 15, 2022
Full approval by the FDA follows tentative approval for the complex drug delivery advice for asthma and chronic obstructive pulmonary disease (COPD) granted by the FDA last week amid a patent dispute.
March 14, 2022
The FDA based its approval on OlympiA trial data, which show the PARP inhibitor has the ability to reduce risks of invasive breast cancer recurrence, second cancers, and death, and to improve overall survival.
March 07, 2022
Steven Yeh, MD, professor of ophthalmology at the Truhlsen Eye Institute at the University of Nebraska Medical Center, explains the delivery mechanism and benefits of Xipere for macular edema.