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

Videos

Roxana Siles, MD, FAAAAI, staff in the Department of Allergy and Immunology at Cleveland Clinic and codirector of the Asthma Center at Cleveland Clinic, discusses the important need for chronic cough therapies and what issues with current treatments should be addressed by next-generation medications. 


Dr Roxana Siles: We Need to Address the Needs of Patients With Refractory/Unexplained Cough

Articles

Eosinophilic esophagitis is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, proliferate in the esophagus, causing difficulties with eating and swallowing.

FDA Approves Dupilumab as First Therapy for Eosinophilic Esophagitis

The treatment was found to improve glycemic control and is indicated to be used in conjunction with diet and exercise.

FDA Approves Eli Lilly's Tirzepatide for T2D

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.

FDA Approves Enhertu for Use in Metastatic Breast Cancer

The drug, oteseconazole, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis in females who are infertile or postmenopausal.



FDA Approves First Drug for Recurrent Vulvovaginal Candidiasis

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. 

What We’re Reading: Mavacamten Approved for HCM; Oklahoma Abortion Bans; Baby Formula Whistleblower

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.

FDA Approves Third Bevacizumab Biosimilar

The expanded use of axi-cel, sold as Yescarta, while not unexpected, nonetheless represents uncharted territory in cancer care. 

FDA Approves Axi-cel in Second Line for LBCL, Expands CAR T Pool by 11,000 in US Alone

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.

What We’re Reading: Epilepsy Drug Approval; Free COVID-19 Testing Ends; EPA Sued

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.