Most-read FDA actions from 2024 in pulmonology
Healio Pulmonology has compiled the top news from the FDA posted in 2024.
The top two FDA pulmonology stories from this year focused on the approval of a once-daily tablet that includes both macitentan and tadalafil (Opsynvi; Johnson & Johnson) for adults with pulmonary arterial hypertension (PAH) and the approval of sotatercept (Winrevair, Merck) for the same patient population.
Additionally, three of the top 10 FDA stories focused on drugs for treating patients with COPD.
Read these and more of the most-read FDA pulmonology stories of 2024 below.
FDA approves combination therapy tablet for pulmonary arterial hypertension
The FDA has approved Opsynvi, a once-daily tablet that includes both macitentan and tadalafil, to treat adults with PAH, according to a manufacturer-issued press release. Read more.
FDA approves sotatercept for pulmonary arterial hypertension
The FDA has approved sotatercept, an activin signaling inhibitor, for treating adults with PAH, according to a manufacturer-issued press release. Also, Mario Naranjo-Tovar, MD, MHS, assistant professor of thoracic medicine & surgery at Lewis Katz School of Medicine at Temple University, shares his Perspective. Read more.
FDA grants 510(k) clearance to snoring-reducing device
The FDA has granted 510(k) clearance to Mouth Guard+, a mandibular advancement device designed to reduce snoring, according to a press release from SnoreLessNow. Read more.
FDA grants breakthrough designation to tezepelumab for COPD
Tezepelumab (Tezspire; Amgen, AstraZeneca) has received an FDA breakthrough therapy designation as a maintenance treatment for patients with moderate to very severe COPD characterized by an eosinophilic phenotype, according to an Amgen press release. Read more.
FDA approves Ohtuvayre as maintenance treatment for COPD
The FDA has approved the phosphodiesterase enzyme 3 and 4 inhibitor ensifentrine, now named Ohtuvayre (Verona Pharma), for treating adults with COPD, according to a manufacturer-issued press release. Read more.
FDA reverses marketing denial orders on Juul vaping devices, products
The FDA announced that it has revoked its previous marketing denial orders to Juul Labs in part because of new case law and further review, according to a press release from the agency. Also, Erika Sward, MA, assistant vice president of nationwide advocacy at the American Lung Association, shares her Perspective. Read more.
ResMed CPAP masks subject to Class I recall over magnetic interference issue
Six reported injuries related to magnets on the headgear of CPAP machines by ResMed Ltd. have resulted in a recall the FDA labels as Class I, the most serious kind, according to an FDA alert. Read more.
FDA approves dupilumab for COPD with type 2 inflammation
The FDA has granted approval to dupilumab (Dupixent; Sanofi, Regeneron) for treating adults with poorly controlled COPD with type 2 inflammation, according to a manufacturer-issued press release. Read more.
Samsung receives FDA authorization for sleep apnea feature on Galaxy Watch
Samsung Electronics has received de novo authorization from the FDA for its sleep apnea feature on the Samsung Galaxy Watch’s “Samsung Health Monitor” app, according to a company press release. Read more.
FDA clears investigational new drug application for inhaled nicotine replacement therapy
The FDA has cleared an investigational new drug application for the RespiRx Nicotine Inhaler (QN-01), an inhaled nicotine replacement therapy, according to a press release from Qnovia. Read more.